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  • 1.
    Alkmark, Mårten
    et al.
    Centre of Perinatal Medicine and Health, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics and Gynecology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Carlsson, Ylva
    Centre of Perinatal Medicine and Health, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics and Gynecology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Brismar Wendel, Sophia
    Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.
    Elden, Helen
    Department of Obstetrics and Gynecology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden; Institute of Health and Caring Sciences, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynecology.
    Jonsson, Maria
    Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
    Ladfors, Lars
    Centre of Perinatal Medicine and Health, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics and Gynecology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Saltvedt, Sissel
    Department of Women's and Children's Health, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.
    Sengpiel, Verena
    Centre of Perinatal Medicine and Health, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics and Gynecology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Wessberg, Anna
    Department of Obstetrics and Gynecology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Wikström, Anna-Karin
    Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
    Hagberg, Henrik
    Centre of Perinatal Medicine and Health, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics and Gynecology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Wennerholm, Ulla-Britt
    Centre of Perinatal Medicine and Health, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics and Gynecology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Efficacy and safety of oral misoprostol vs transvaginal balloon catheter for labor induction: An observational study within the SWEdish Postterm Induction Study (SWEPIS)2021In: Acta Obstetricia et Gynecologica Scandinavica, ISSN 0001-6349, E-ISSN 1600-0412, Vol. 100, no 8, p. 1463-1477Article in journal (Refereed)
    Abstract [en]

    INTRODUCTION: Induction of labor is increasing in the world. A common indication for Induction of labor is late term and postterm pregnancy at 41 gestational week and thereafter. We aimed to evaluate if there are any differences regarding efficacy, safety, and women's childbirth experience between oral misoprostol and transvaginal balloon catheter for cervical ripening in women with a low-risk singleton pregnancy and induction of labor at 41+0 to 42+0-1 gestational weeks.

    MATERIAL AND METHODS: In this observational study, based on data from Swedish Postterm Induction Study (SWEPIS), a multicenter randomized controlled trial, a total of 1 213 women with a low-risk singleton pregnancy at 41 to 42 gestational weeks were induced with oral misoprostol (n=744) or transvaginal balloon catheter (n=469) at 15 Swedish delivery hospitals. The primary efficacy outcome was vaginal delivery within 24 hours and primary safety outcomes were neonatal and maternal composite adverse outcomes. Secondary outcomes included time-to-vaginal delivery and mode of delivery. Women's childbirth experience was assessed with the Childbirth Experience Questionnaire (CEQ 2.0) and visual analogue scale. We present crude and adjusted mean differences and relative risks (RR) with 95% confidence interval (CI). Adjustment was performed for a propensity score based on delivery hospital and baseline characteristics including Bishop score.

    RESULTS: Vaginal delivery within 24 hours was significantly lower in the misoprostol compared with the balloon catheter group (46.5% [346/744] vs 62.7% [294/469]; adjusted RR 0.76 [95% CI 0.64; 0.89]). Primary neonatal and maternal safety outcomes did not differ between groups (neonatal composite 3.5% [36/744] vs 3.2% [15/469]; adjusted RR 0.77 [95% CI 0.31; 1.89]; maternal composite (2.3% [17/744] vs 1.9% [9/469]; adjusted RR 1.70 [95% CI 0.58; 4.97]). Adjusted mean time-to-vaginal delivery was increased by 3.8 hours (95% CI 1.3; 6.2) in the misoprostol group. Non-operative vaginal delivery and cesarean delivery rates did not differ. Women's childbirth experience was positive overall and similar in both groups.

    CONCLUSION: Induction of labor with oral misoprostol compared with a transvaginal balloon catheter was associated with a lower probability of vaginal delivery within 24 hours and a longer time-to-vaginal delivery. However, primary safety outcomes, non-operative vaginal delivery and women's childbirth experience were similar in both groups. Therefore, both methods can be recommended in women with low-risk postdate pregnancies.

  • 2.
    Alkmark, Mårten
    et al.
    Centre of Perinatal Medicine & Health, Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden.
    Wennerholm, Ulla-Britt
    Centre of Perinatal Medicine & Health, Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden.
    Saltvedt, Sissel
    Department of Women's and Children's Health, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.
    Bergh, Christina
    Region Västra Götaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden.
    Carlsson, Ylva
    Centre of Perinatal Medicine & Health, Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden.
    Elden, Helen
    Region Västra Götaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden; Institute of Health and Caring Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynaecology.
    Jonsson, Maria
    Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
    Ladfors, Lars
    Centre of Perinatal Medicine & Health, Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden.
    Sengpiel, Verena
    Centre of Perinatal Medicine & Health, Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden.
    Wesström, Jan
    Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden; Center for Clinical Research Dalarna, Falu Hospital, Falun, Sweden .
    Hagberg, Henrik
    Centre of Perinatal Medicine & Health, Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden.
    Svensson, Mikael
    School of Public Health & Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Induction of labour at 41 weeks of gestation versus expectant management and induction of labour at 42 weeks of gestation: a cost-effectiveness analysis2022In: British Journal of Obstetrics and Gynecology, ISSN 1470-0328, E-ISSN 1471-0528, Vol. 129, no 13, p. 2157-2165Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: To assess the cost-effectiveness of induction of labour (IOL) at 41 weeks of gestation compared with expectant management until 42 weeks of gestation.

    DESIGN: A cost-effectiveness analysis alongside the Swedish Postterm Induction Study (SWEPIS), a multicentre, randomised controlled superiority trial.

    SETTING: Fourteen Swedish hospitals during 2016-2018.

    POPULATION: Women with an uncomplicated singleton pregnancy with a fetus in cephalic position were randomised at 41 gestational weeks to IOL or to expectant management and induction at 42 gestational weeks.

    METHODS: Health benefits were measured in life years and quality adjusted life years (QALYs) for mother and child. Total cost per birth was calculated, including healthcare costs from randomisation to discharge after the delivery, for mother and child. Incremental cost-effectiveness ratios (ICERs) were calculated by dividing the difference in mean cost between the trial arms by the difference in life years and QALYs, respectively. Sampling uncertainty was evaluated using non-parametric bootstrapping.

    MAIN OUTCOME MEASURES: The cost per gained life year and per gained QALY.

    RESULTS: The differences in life years and QALYs gained were driven by the difference in perinatal mortality alone. The absolute risk reduction in mortality was 0.004 (from 6/1 373 to 0/1 373). Based on Swedish life tables, this gives a mean gain in discounted life years and QALYs by 0.14 and 0.12 per birth, respectively. The mean cost per birth was €4,108 in the IOL group (n=1 373) and €4,037 in the expectant management group (n=1 373), mean difference €71 (95% CI -€232 to €379). The ICER for IOL compared with expectant management was €545 per life year gained and €623 per QALY gained. Confidence intervals were relatively wide and included the possibility that IOL had both lower costs and better health outcomes.

    CONCLUSIONS: IOL at 41 gestational weeks results in a better health outcome and no significant difference in costs. IOL is cost-effective compared to expectant management until 42 gestational weeks using standard threshold values for acceptable cost per life year/QALY.

  • 3.
    Arntyr Hellgren, P.
    et al.
    Department of Obstetrics and Gynaecology, Örebro University Hospital, Örebro, Sweden.
    Simmons, D.
    School of Medicine, Western Sydney University, Campbelltown NSW, Australia.
    Hanson, U.
    Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden.
    Magnuson, A.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynaecology, Örebro University Hospital, Örebro, Sweden.
    Birth trauma in babies born to women with and without type 1 diabetes in Sweden 1998-2012: relationship with maternal and baby weight2017In: 49th Annual Meeting of the Diabetic Pregnancy Study Group: Abstract book, 2017, p. 66-67Conference paper (Other academic)
    Abstract [en]

    We compared birth trauma rates in pregnancies among women with and without type 1 diabetes (DM1) and tested the relationship with maternal body mass index (BMI) and large for gestational age (LGA) as a risk factor. This is a population-based cohort study 1998-2012 using the Swedish Medical Birth Registry (MBR) which includes 99% of Swedish pregnancies. All pregnancies up until gestational week 41 were included. We excluded mothers with other types of diabetes, duplex pregnancies and all pregnancies ending with a caesarean section (51.1% and 16.5% in women with and without DM1 respectively). The incidence of birth trauma was adjusted for BMI, maternal age, parity, Nordic or non-Nordic origin, smoking, chronic hypertensive disease, LGA and the baby ́s sex using logistic regression. This left 2,758 and 783,412 births with complete data among DM1 and control mothers respectively. The mean BMI, maternal age and gestational age at birth in full weeks was 25.6 (SD 4.5), 30.0 (SD 5.1) and 37.9 (SD 1.9) respectively among women with DM1 and 24.2 (SD 4.3), 29.7 (SD 5.1) and 38.9 (SD 1.5) respectively among controls. Preliminary results show that birth trauma rates did not vary significantly with increasing BMI compared with the reference BMI (18.50-24.9 kg/m2) among women with DM1 (odds ratios (OR) with increasing BMI (<18.49, 25.0-29.9, 30.0-34.9, >35.0 kg/m2) were 1.9 (95%CI 0.2-15.7), 1.0 (95%CI 0.7-1.5), 0.5 (95%CI 0.2-1.0), 1.1 (95%CI 0.5-2.4) respectively). Conversely, among controls, the OR for birth trauma increasedwith increasing BMI: 0.7 (95%CI 0.6-0.9), 1.4 (95%CI 1.3-1.5), 1.8 (95%CI 1.6-2.0), and 2.2 (95%CI 1.9-2.4) respectively. However, birth trauma was 3.9 (95%CI 2.7-5.7) and 7.0 (95%CI 6.5-7.5) fold more common after adjustment with LGA among women with andwithout DM1 respectively. We conclude that birth trauma rates are associated with LGA with comparatively greater impact among women without, than with, DM1. LGA is clearly an important outcome in its own right and a predictor of birth trauma. We hypothesise that the reduced risk of birth trauma from LGA among women with DM1 is due to increased monitoring with multiple ultrasounds to determine the fetal growth rate, along with earlier planned delivery (including earlier induction with vaginal delivery ata lower birthweight or caesarean section). While more research is needed to find better ways to reduce LGA in DM1, many of the obese control women would have undiagnosed/untreated GDM due to the Swedish criteria at the time (2 hours >=9.0mmol/l). Besidestreating lower levels of hyperglycaemia during pregnancy, the frequency of growth monitoring in obese mothers to reduce their babies’ risk of birth trauma due to LGA, needs to be evaluated. Life course cost effectiveness analyses would be useful.

  • 4. Backman [Fadl], Helena
    Medicinsk ordlista1990Book (Other academic)
  • 5.
    Backman, Helena E.
    et al.
    Örebro University, School of Health Sciences. Department of Obstetrics and Gynaecology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Karefylakis, Christos
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Internal Medicine.
    Schwarcz, Erik
    Department of Internal Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Magnuson, Anders
    Department of Statistics, Clinical Epidemiology and Biostatistics, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Branzell, Ida
    Division of Laboratory Medicine, Department of Clinical Chemistry, Örebro University Hospital, Örebro, Sweden.
    Nolan, Christopher J.
    School of Medicine and Psychology, College of Health and Medicine, Australian National University, Acton, Australian Capital Territory, Australia.
    Simmons, David
    Örebro University, School of Medical Sciences. Macarthur Clinical School, Western Sydney University, Campbelltown, New South Wales, Australia.
    Diagnosis of Gestational Diabetes Mellitus: How Should We Measure Glucose?2024In: Diabetes Care, ISSN 0149-5992, E-ISSN 1935-5548, article id dc231557Article in journal (Refereed)
  • 6.
    Bergengren, Lovisa
    et al.
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology.
    Ryen, Linda
    University Health Care Research Centre, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Flodström, Clelia
    Department of Women´s health, Örebro University Hospital, Örebro, Sweden.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynaecology.
    Udumyan, Ruzan
    Örebro University, School of Medical Sciences.
    Karlsson, Mats
    Örebro University, School of Medical Sciences. Department of Laboratory Medicine.
    Helenius, Gisela
    Örebro University, School of Medical Sciences. Department of Laboratory Medicine.
    Effectiveness and costs of implemented primary HPV cervical screening: a populationbased cohort studyManuscript (preprint) (Other academic)
  • 7.
    Carlsson, Ylva
    et al.
    Department of Obstetrics and Gynaecologyhe, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.
    Bergman, Lina
    Department of Obstetrics and Gynaecologyhe, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.
    Zaigham, Mehreen
    Department of Clinical Sciences Lund, Lund University, Lund, Sweden; Department of obstetrics and gynecology, Skåne University Hospital, Malmö, Sweden.
    Linden, Karolina
    Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Andersson, Ola
    Department of Clinical Sciences Lund, Pediatrics, Lund University and Skåne University Hospital, Malmö, Sweden.
    Veje, Malin
    Department of Infectious Diseases, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Infectious Diseases, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Sandström, Anna
    Department of Medicine, Solna, Clinical Epidemiology Division, Karolinska Institutet, Stockholm, Sweden.
    Wikström, Anna-Karin
    Department of Women's and Childen's Health, Uppsala University, Uppsala, Sweden.
    Östling, Hanna
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynaecology.
    Domellöf, Magnus
    Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.
    Blomberg, Marie
    Department of Obstetrics and Gynecology and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
    Brismar Wendel, Sophia
    Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital, Stockholm, Sweden; Department of Women's Health, Danderyd Hospital, Stockholm, Sweden.
    Åden, Ulrika
    Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden; Neonatal unit, Karolinska University Hospital, Stockholm, Sweden.
    Sengpiel, Verena
    Department of Obstetrics and Gynaecologyhe, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden .
    COVID-19 in Pregnancy and Early Childhood (COPE): study protocol for a prospective, multicentre biobank, survey and database cohort study2021In: BMJ Open, E-ISSN 2044-6055, Vol. 11, no 9, article id e049376Article in journal (Refereed)
    Abstract [en]

    INTRODUCTION: There is limited knowledge on how the SARS-CoV-2 affects pregnancy outcomes. Studies investigating the impact of COVID-19 in early pregnancy are scarce and information on long-term follow-up is lacking.The purpose of this project is to study the impact of COVID-19 on pregnancy outcomes and long-term maternal and child health by: (1) establishing a database and biobank from pregnant women with COVID-19 and presumably non-infected women and their infants and (2) examining how women and their partners experience pregnancy, childbirth and early parenthood in the COVID-19 pandemic.

    METHODS AND ANALYSIS: This is a national, multicentre, prospective cohort study involving 27 Swedish maternity units accounting for over 86 000 deliveries/year. Pregnant women are included when they: (1) test positive for SARS-CoV-2 (COVID-19 group) or (2) are non-infected and seek healthcare at one of their routine antenatal visits (screening group). Blood, as well as other biological samples, are collected at different time points during and after pregnancy. Child health up to 4 years of age and parent experience of pregnancy, delivery, early parenthood, healthcare and society in general will be examined using web-based questionnaires based on validated instruments. Short- and long-term health outcomes will be collected from Swedish health registers and the parents' experiences will be studied by performing qualitative interviews.

    ETHICS AND DISSEMINATION: Confidentiality aspects such as data encryption and storage comply with the General Data Protection Regulation and with ethical committee requirements. This study has been granted national ethical approval by the Swedish Ethical Review Authority (dnr 2020-02189 and amendments 2020-02848, 2020-05016, 2020-06696 and 2021-00870) and national biobank approval by the Biobank Väst (dnr B2000526:970). Results from the project will be published in peer-reviewed journals.

    TRIAL REGISTRATION NUMBER: NCT04433364.

  • 8.
    de Brun, Maryam
    et al.
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynecology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Region Västmanland-Uppsala University, Centre for Clinical Research, Västmanland Hospital Västerås, Sweden.
    Johansson, Naimi
    Örebro University, School of Health Sciences. Örebro University Hospital. University Health Care Research Center.
    Simmons, David
    Örebro University, School of Medical Sciences. Macarthur Clinical School, Western Sydney University, Campbelltown, Australia.
    Montgomery, Scott
    Örebro University, School of Medical Sciences. Clinical Epidemiology and Biostatistics, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Clinical Epidemiology Division, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden. Department of Epidemiology and Public Health, University College London, UK .
    Berntorp, Kerstin
    Genomics, Diabetes and Endocrinology Research Unit, Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.
    Jansson, Stefan
    Örebro University, School of Medical Sciences. Örebro University Hospital. University Health Care Research Center.
    Wennerholm, Ulla-Britt
    Department of Obstetrics and Gynecology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg and Region Västra Götaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden.
    Wikström, Anna-Karin
    Department of Women’s and Children’s Health, Uppsala University. Akademiska sjukhuset, Uppsala.
    Strevens, Helena
    Department of Obstetrics and Gynecology, Skåne University Hospital, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
    Ahlsson, Fredrik
    Department of Women’s and Children’s Health, Uppsala University. Akademiska sjukhuset, Uppsala.
    Sengpiel, Verena
    Department of Obstetrics and Gynecology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg and Region Västra Götaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden.
    Storck-Lindholm, Elisabeth
    Department of Obstetrics and Gynecology Södersjukhuset, Karolinska Institute, Sweden.
    Persson, Martina
    Department of Clinical Science and Education Karolinska Institute, Department of Medicine, Clinical Epidemiology Karolinska Institutet and Sachsska Childrens´ and Youth Hospital Stockholm, Sweden.
    Petersson, Kerstin
    Department of Obstetrics and Gynecology Södersjukhuset, Umeå University, Sweden.
    Ursing, Carina
    Södersjukhuset, Stockholm.
    Ryen, Linda
    Örebro University, School of Health Sciences. Örebro University Hospital. University Health Care Research Center.
    Backman, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynecology.
    Healthcare cost consequences of changing diagnostic criteria for gestational diabetes mellitus (CDC4G) in Sweden: Alongside a stepped wedge cluster randomised trialManuscript (preprint) (Other academic)
  • 9.
    de Brun, Maryam
    et al.
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynecology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Magnusson, Anders
    Department of Obstetrics and Gynecology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Clinical Epidemiology and Biostatistics, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Montgomery, Scott
    Örebro University, School of Medical Sciences. Clinical Epidemiology and Biostatistics, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Clinical Epidemiology Division, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden. Department of Epidemiology and Public Health, University College London, UK .
    Patil, Snehal
    Örebro University, School of Medical Sciences. Clinical Epidemiology and Biostatistics, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Simmons, David
    Örebro University, School of Medical Sciences. Macarthur Clinical School, Western Sydney University, Campbelltown, Australia.
    Berntorp, Kerstin
    Genomics, Diabetes and Endocrinology Research Unit, Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.
    Wennerholm, Ulla-Britt
    Department of Obstetrics and Gynecology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg and Region Västra Götaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden.
    Jansson, Stefan P. O.
    Örebro University, School of Medical Sciences. Örebro University Hospital. University Health Care Research Center.
    Wikström, Anna-Karin
    Department of Women’s and Children’s Health, Uppsala University. Akademiska sjukhuset, Uppsala.
    Strevens, Helena
    Department of Obstetrics and Gynecology, Skåne University Hospital, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
    Ahlsson, Fredrik
    Department of Women’s and Children’s Health, Uppsala University. Akademiska sjukhuset, Uppsala.
    Sengpiel, Verena
    Department of Obstetrics and Gynecology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg and Region Västra Götaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden.
    Schwarcz, Erik
    Department of Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Storck-Lindholm, Elisabeth
    Department of Obstetrics and Gynecology Södersjukhuset, Karolinska Institute, Sweden.
    Persson, Martina
    Department of Clinical Science and Education Karolinska Institute, Department of Medicine, Clinical Epidemiology Karolinska Institutet and Sachsska Childrens´ and Youth Hospital Stockholm, Sweden.
    Petersson, Kerstin
    Department of Obstetrics and Gynecology Södersjukhuset, Umeå University, Sweden.
    Ryen, Linda
    Örebro University, School of Health Sciences. Örebro University Hospital. University Health Care Research Center.
    Ursing, Carina
    Södersjukhuset, Stockholm.
    Hildén, Karin
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynecology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Backman, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynecology.
    Changing diagnostic criteria for gestational diabetes (CDC4G) in Sweden: a stepped wedge cluster randomised trialManuscript (preprint) (Other academic)
  • 10. Devlieger, Roland
    et al.
    Fadl, Helena
    Örebro University, School of Medical Sciences.
    Deruelle, Philippe
    Assessment of fetal and neonatal growth (including growth pattern in diabetes)2016In: 2016 AUDIT MEETING: Diabetic Pregnancy Study Group of the EASD, 2016Conference paper (Refereed)
  • 11.
    Diurlin, S.
    et al.
    Institute of Medicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Patil, S.
    Örebro University, School of Medical Sciences. Clinical Epidemiology and Biostatistics.
    Lindblad, U.
    Institute of Medicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Daka, B.
    Institute of Medicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Hellgren, M. I.
    Institute of Medicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Backman, H.
    Örebro University Hospital. Örebro University, School of Health Sciences. Dept of Obstetrics and Gynecology.
    Gestational diabetes diagnosis in the Swedish Pregnancy Register2023In: Diabetologia, ISSN 0012-186X, E-ISSN 1432-0428, Vol. 66, no Suppl. 1, p. S264-S265, article id 521Article in journal (Other academic)
    Abstract [en]

    Background and aims: The Changing Diagnostic Criteria for Gestational Diabetes (GDM) study (CDC4G) is a stepped wedged randomized controlled trial in Sweden on the effects of introducing the 2013 WHO criteriaf or diagnosing GDM. Almost all Swedish pregnancies are registered in the Swedish Pregnancy Register (SPR). The CDC4G study provides a unique opportunity to validate the GDM diagnosis in the SPR. We aim to 1) validate the diagnosis of GDM in the SPR using the laboratory values from the oral glucose tolerance tests (OGTT) in the CDC4G study as the gold standard; 2) explore effects of change in diagnostic criteria on validity and prevalence of the diagnosis of GDM. Secondary aim is to investigate whether incident GDM diagnoses during pregnancy are recorded by the midwife when entering the follow-up postpartum registration in the SPR.

    Materials and methods: Data from the SPR were compared with data from the CDC4G eCRF (gold standard measurements: venous OGTT values fasting, 1-h and 2-h) among 6080 screened individuals in 2018. We also investigated if the GDM diagnosis, set at the maternity ward was registered by the midwives at the postpartum follow-up (SPR tickbox). We present the sensitivity, specificity, positive (PPV) and negative (NPV) predictive value for each question. The study was approved by the Uppsala-Örebro regional Ethical Review board (2016/487), and by the Swedish Ethical Review Authority (2019/02148, 2020/02856, 2021/02055).

    Results: Validating the ICD-code GDM (O24.4) in the Swedish Pregnancy Register resulted in 84.7% sensitivity, 96.7% specificity, PPV of 91.8%, and NPV of 93.5%. The prevalence of the GDM diagnosis more than tripled using the new criteria (Table 1). Both the sensitivity and specificity of the follow-up postpartum registration of GDM were considerably lower than for the GDM ICD-code, 76.6% and 87.6%, respectively. There were some minor differences in the accuracy of the registration before and after the switch to the new criteria for GDM, see table 1.

    Conclusion: The coding of GDM in clinical practice, that is transferred to the SPR needs to be improved. We recommend researchers to use data based on ICD coding, instead of manually entered SPR data, until the quality of the variable has improved.

  • 12. Englund-Ögge, Linda
    et al.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital.
    Millde-Luthander, Charlotte
    Diabetes och graviditet2021In: Obstetrik, Studentlitteratur AB, 2021, 3, p. 387-401Chapter in book (Refereed)
  • 13.
    Fadl, Helena
    Örebro University, School of Health and Medical Sciences.
    Gestational diabetes mellitus in Sweden: screening, outcomes, and consequences2012Doctoral thesis, comprehensive summary (Other academic)
    List of papers
    1. Fasting capillary glucose as a screening test for gestational diabetes mellitus
    Open this publication in new window or tab >>Fasting capillary glucose as a screening test for gestational diabetes mellitus
    2006 (English)In: BJOG: an International Journal of Obstetrics and Gynaecology, ISSN 1470-0328, Vol. 113, no 9, p. 1067-71Article in journal (Refereed) Published
    Abstract [en]

    Objective: To evaluate fasting capillary glucose as a screening test for gestational diabetes mellitus (GDM) compared with traditional risk factors and repeated random capillary glucose measurements.

    Design: Cross-sectional, population-based study.

    Setting: Maternal Health Care Clinics in Orebro County, Sweden.

    Population: An unselected population of women without diabetes.

    Methods: Fasting capillary glucose levels were measured at gestational weeks 28-32. Random capillary glucose levels were measured four to six times during pregnancy. Traditional risk factors for GDM were registered. GDM was diagnosed using a 75-g oral glucose tolerance test.

    Main outcome measures: Sensitivity, specificity, likelihood ratios.

    Results: In 55 of 3616 women participating in the study, GDM was diagnosed before 34 weeks of gestation. For fasting capillary glucose cutoff values between 4.0 and 5.0 mmol/l, sensitivity was in the range between 87 and 47% and specificity between 51 and 96%. Using a combined screening model of traditional risk factors with fasting capillary glucose at various cutoff values increased the sensitivity only slightly compared with using fasting capillary glucose alone.

    Conclusion: In this Swedish, unselected, low-risk population, fasting capillary glucose measurements were found to be an acceptable and useful screening test for GDM.

    Place, publisher, year, edition, pages
    Oxford: Blackwell Publishing, 2006
    Keywords
    fasting capillary glucose; gestational diabetes mellitus; screening; sensitivity; specificity
    National Category
    Obstetrics, Gynecology and Reproductive Medicine
    Research subject
    Obstetrics and Gynaecology
    Identifiers
    urn:nbn:se:oru:diva-4668 (URN)10.1111/j.1471-0528.2006.01032.x (DOI)000240030600015 ()16956338 (PubMedID)2-s2.0-33748161345 (Scopus ID)
    Note

    Comment in: BJOG. 2007 Feb;114(2):237-8; author reply 238-9. BJOG. 2007 Mar;114(3):372; author reply 373.

    Available from: 2008-11-11 Created: 2008-11-11 Last updated: 2020-12-01Bibliographically approved
    2. Maternal and neonatal outcomes and time trends of gestational diabetes mellitus in Sweden from 1991 to2003
    Open this publication in new window or tab >>Maternal and neonatal outcomes and time trends of gestational diabetes mellitus in Sweden from 1991 to2003
    2010 (English)In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 27, no 4, p. 436-441Article in journal (Refereed) Published
    Abstract [en]

    Aims To determine maternal and neonatal outcomes for women with gestational diabetes mellitus (GDM) in Sweden during 1991–2003, and to compare the outcomes in the two time periods.

    Methods This is a population-based cohort study using the Swedish Medical Birth Register data for the period 1991–2003. There were 1 260 297 women with singleton pregnancies registered during this time, of whom 10 525 were diagnosed with GDM, based on a 75 g oral glucose tolerance test. The main diagnostic criteria were fasting capillary whole blood glucose ≥ 6.1 mmol⁄l and 2 h blood glucose ≥ 9.0 mmol⁄l.

    Results Maternal characteristics differed significantly between the GDM and non-GDM group. Adjusted odds ratios (OR) were as follows: for pre-eclampsia, 1.81 (95% confidence interval (CI) 1.64–2.00); for shoulder dystocia, 2.74 (2.04–3.68); and for Caesarean section, 1.46 (1.38–1.54).No difference was seen in perinatal mortality, stillbirth rates, Apgar scores, fetal distress or transient tachypnoea. There was a markedly higher risk of large for gestational age,OR3.43 (3.21–3.67), and Erb’s palsy, OR 2.56 (1.96–3.32), in the GDMgroup, and statistically significant differences in prematurity < 37 weeks, birthweight > 4.5 kg, and major malformation, OR 1.19–1.71. No statistically significant improvement in outcomes was seen between the two study periods.

    Conclusions Women with GDM have higher risks of pre-eclampsia, shoulder dystocia and Caesarean section. Their infants are often large for gestational age and have higher risks of prematurity, Erb’s palsy and major malformations. These outcomes did not improve over time.

    Place, publisher, year, edition, pages
    Malden 02148, MA USA: Wiley-Blackwell, 2010
    Keywords
    gestational diabetes mellitus, maternal outcome, neonatal outcome
    National Category
    Medical and Health Sciences Obstetrics, Gynecology and Reproductive Medicine
    Research subject
    Medicine
    Identifiers
    urn:nbn:se:oru:diva-21259 (URN)10.1111/j.1464-5491.2010.02978.x (DOI)000276466600011 ()2-s2.0-77950651218 (Scopus ID)
    Available from: 2012-01-23 Created: 2012-01-23 Last updated: 2023-12-08Bibliographically approved
    3. Outcomes of gestational diabetes in Sweden depending on country of birth
    Open this publication in new window or tab >>Outcomes of gestational diabetes in Sweden depending on country of birth
    (Swedish)Manuscript (preprint) (Other academic)
    Keywords
    Gestational diabetes mellitus (GDM), ethnicity, LGA, maternal and neonatal outcomes, maternal anthropometrics
    National Category
    Medical and Health Sciences Obstetrics, Gynecology and Reproductive Medicine
    Research subject
    Medicine
    Identifiers
    urn:nbn:se:oru:diva-21269 (URN)
    Note

    Funding: Örebro County Council Research Funds, Sweden.

    Available from: 2012-01-23 Created: 2012-01-23 Last updated: 2019-04-24Bibliographically approved
    4. Gestational diabetes mellitus is associated with later cardiovascular disease, particularly among overweight women: a Swedish population based case-control study
    Open this publication in new window or tab >>Gestational diabetes mellitus is associated with later cardiovascular disease, particularly among overweight women: a Swedish population based case-control study
    Show others...
    (English)Manuscript (preprint) (Other academic)
    National Category
    Medical and Health Sciences Obstetrics, Gynecology and Reproductive Medicine
    Research subject
    Medicine
    Identifiers
    urn:nbn:se:oru:diva-21270 (URN)
    Note

    Helena Fadl is also affiliated to Maternal Health Care Unit,Primary Care, Örebro, Sweden and to Department of Obstetrics and Gynaecology, Örebro University Hospital, Örebro, Sweden Ulf Hanson is affliated to Department of Obstetrics and Gynaecology, Örebro University Hospital, Örebro, Sweden and to Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden Ingrid Östlund is also affiliated to Department of Obstetrics and Gynaecology, Örebro University Hospital, Örebro, Sweden Scott Montgomery is also affiliated to Clinical Epidemiology Unit, Karolinska Institutet, Stockholm, Sweden; Department of Primary Care and Public Health, Charing Cross Hospital, Imperial College, London, UK Erik Schwarcz is also affiliated to Department of Internal Medicine, Örebro University Hospital, Sweden

    Available from: 2012-01-23 Created: 2012-01-23 Last updated: 2019-04-24Bibliographically approved
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  • 14.
    Fadl, Helena E.
    et al.
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden.
    Gärdefors, Susanne
    Department of Obstetrics and Gynecology, School of Health and Medical Sciences, Örebro University, Örebro, Sweden.
    Hjertberg, Ragnhild
    UltraGyn Clinic, Stockholm, Sweden.
    Nord, Eva
    Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden.
    Persson, Bengt
    Karolinska Institute, Stockholm, Sweden.
    Schwarcz, Erik
    Department of Internal Medicine, School of Health and Medical Sciences, Örebro University, Örebro, Sweden .
    Åman, Jan
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Department of Pediatrics, Örebro University Hospital, Örebro, Sweden.
    Östlund, Ingrid K.
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden.
    Hanson, Ulf S. B.
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Department of Children’s and Women’s Health, Uppsala University, Uppsala, Sweden.
    Randomized controlled study in pregnancy on treatment of marked hyperglycemia that is short of overt diabetes2015In: Acta Obstetricia et Gynecologica Scandinavica, ISSN 0001-6349, E-ISSN 1600-0412, Vol. 94, no 11, p. 1181-1187Article in journal (Refereed)
    Abstract [en]

    Introduction: A randomized multicenter study was conducted in the Stockholm-orebro areas in Sweden to evaluate how treatment aiming at normoglycemia affects fetal growth, pregnancy and neonatal outcome in pregnant women with severe hyperglycemia.

    Material and methods: Pregnant women with hyperglycemia defined as fasting capillary plasma glucose <7.0 mmol/L and a two-hour plasma glucose value 10.0 and <12.2 mmol/L following a 75-g oral glucose tolerance test (OGTT) diagnosed before 34 weeks of gestation were randomized to treatment (n=33) or controls (n=36). Women assigned to the control group were blinded for the OGTT results and received routine care. The therapeutic goal was fasting plasma glucose 4-5 mmol/L, and <6.5 mmol/L after a meal. Primary outcomes were size at birth and number of large-for-gestational age (>90th percentile) neonates. Secondary outcomes were pregnancy complications, neonatal morbidity and glycemic control.

    Results: The planned number of participating women was not reached. There was a significantly reduced rate of large-for-gestational age neonates, 21 vs. 47%, P<0.05. Group differences in pregnancy complications and neonatal morbidity were not detected because of limited statistical power. In total, 66.7% of the women in the intervention group received insulin. Of all measured plasma glucose values, 64.1% were in the target range, 7.2% in the hypoglycemic range and 28.7% above target values. There were no cases of severe hypoglycemia.

    Conclusions: Aiming for normalized glycemia in a pregnancy complicated by severe hyperglycemia reduces fetal growth but is associated with an increased rate of mild hypoglycemia.

  • 15.
    Fadl, Helena E.
    et al.
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology, Örebro University Hospital, Örebro, Sweden.
    Simmons, David
    School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.
    Trends in diabetes in pregnancy in Sweden 1998-20122016In: BMJ Open Diabetes Research & Care, ISSN 2052-4897, Vol. 4, no 1, article id e000221Article in journal (Refereed)
    Abstract [en]

    Objective: Diabetes in pregnancy has been shown to increase in parallel with the increasing prevalence of obesity. In this national population-based study, we analyzed the trends for gestational diabetes mellitus (GDM), type 1 diabetes in pregnancy, and type 2 diabetes in pregnancy in Sweden between 1998 and 2012.

    Research design and methods: A population-based cohort study using the Swedish national medical birth registry data. The time periods were categorized into 3-year intervals and adjusted for maternal body mass index (BMI), ethnicity, and age in a logistic regression.

    Results: Each type of diabetes increased over the studied 15-year period. Type 1 diabetes increased by 33.2% (22.2-45.3) and type 2 diabetes by 111% (62.2-174.4) in the adjusted model. Nordic women had the highest prevalence of type 1 diabetes (0.47%) compared with other ethnic groups. The increase in GDM and, to a lesser extent, type 2 diabetes was explained by country of birth, BMI, and maternal age. The prevalence of GDM in Nordic women (0.7-0.8%) did not increase significantly over the time period.

    Conclusions: All types of diabetes in pregnancy increased over the 15-year time period in Sweden. Maternal pre-pregnancy BMI remains the key factor explaining the increase in GDM/type 2 diabetes. How to turn around the growing prevalence of diabetes in pregnancy, with its short-term and long-term health effects on both mother and child, requires population-based interventions that reduce the likelihood of entering pregnancy with a raised BMI.

  • 16.
    Fadl, Helena E.
    et al.
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden.
    Östlund, I. K. M.
    Department of Obstetrics and Gynaecology, Örebro University Hospital, Örebro, Sweden.
    Magnuson, A. F. K.
    Statistical and Epidemiology Unit, Örebro University Hospital, Örebro, Sweden.
    Hanson, U. S. B.
    Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden.
    Maternal and neonatal outcomes and time trends of gestational diabetes mellitus in Sweden from 1991 to20032010In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 27, no 4, p. 436-441Article in journal (Refereed)
    Abstract [en]

    Aims To determine maternal and neonatal outcomes for women with gestational diabetes mellitus (GDM) in Sweden during 1991–2003, and to compare the outcomes in the two time periods.

    Methods This is a population-based cohort study using the Swedish Medical Birth Register data for the period 1991–2003. There were 1 260 297 women with singleton pregnancies registered during this time, of whom 10 525 were diagnosed with GDM, based on a 75 g oral glucose tolerance test. The main diagnostic criteria were fasting capillary whole blood glucose ≥ 6.1 mmol⁄l and 2 h blood glucose ≥ 9.0 mmol⁄l.

    Results Maternal characteristics differed significantly between the GDM and non-GDM group. Adjusted odds ratios (OR) were as follows: for pre-eclampsia, 1.81 (95% confidence interval (CI) 1.64–2.00); for shoulder dystocia, 2.74 (2.04–3.68); and for Caesarean section, 1.46 (1.38–1.54).No difference was seen in perinatal mortality, stillbirth rates, Apgar scores, fetal distress or transient tachypnoea. There was a markedly higher risk of large for gestational age,OR3.43 (3.21–3.67), and Erb’s palsy, OR 2.56 (1.96–3.32), in the GDMgroup, and statistically significant differences in prematurity < 37 weeks, birthweight > 4.5 kg, and major malformation, OR 1.19–1.71. No statistically significant improvement in outcomes was seen between the two study periods.

    Conclusions Women with GDM have higher risks of pre-eclampsia, shoulder dystocia and Caesarean section. Their infants are often large for gestational age and have higher risks of prematurity, Erb’s palsy and major malformations. These outcomes did not improve over time.

  • 17.
    Fadl, Helena E.
    et al.
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden.
    Östlund, Ingrid K. M.
    Department of Obstetrics and Gynecology, Örebro University Hospital, Örebro, Sweden.
    Hanson, Ulf S. B.
    Department of Women’s and Children’ Health, Uppsala University, Uppsala County, Sweden.
    Outcomes of gestational diabetes in Sweden depending on country of birthManuscript (preprint) (Other academic)
  • 18.
    Fadl, Helena
    et al.
    Örebro University Hospital. Department of Obstetrics and Gynaecology, Örebro University Hospital, Örebro, Sweden.
    Magnuson, A.
    Östlund, Ingrid
    Örebro University Hospital. Department of Obstetrics and Gynaecology, Örebro University Hospital, Örebro, Sweden.
    Montgomery, Scott
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Örebro University Hospital. Clinical Epidemiology Unit, Karolinska Institutet, Stockholm, Sweden.
    Hanson, Ulf
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Clinical Epidemiology Unit, Karolinska Institutet, Stockholm, Sweden.
    Schwarcz, Erik
    Örebro University, School of Health Sciences. Department of Internal Medicine, Faculty of Health and Medical Sciences, Örebro University, Örebro, Sweden.
    Gestational diabetes mellitus and later cardiovascular disease: a Swedish population based case-control study2014In: British Journal of Obstetrics and Gynecology, ISSN 1470-0328, E-ISSN 1471-0528, Vol. 121, no 12, p. 1530-1536Article in journal (Refereed)
    Abstract [en]

    Objective: To identify if gestational diabetes mellitus (GDM) is a clinically useful marker of future cardiovascular disease (CVD) risk and if GDM combined with other risks (smoking, hypertension or body mass) identifies high-risk groups.

    Design: Population-based matched case-control study.

    Setting: National Swedish register data from 1991 to 2008.

    Population: A total of 2639 women with a cardiovascular event and matched controls.

    Methods: Conditional logistic regression examined associations with CVD before and after adjustment for conventional risk factors and confounders. Effect modification for the association of GDM with CVD by body mass index (BMI), smoking and chronic hypertension was assessed by stratification and interaction testing. Adjustment for diabetes post-pregnancy evaluated its mediating role.

    Main outcome measures: Inpatient diagnoses or causes of death identifying ischemic heart disease, ischemic stroke, atherosclerosis or peripheral vascular disease.

    Results: The adjusted odds ratios (and 95% confidence intervals) for the association of CVD with GDM are 1.51 (1.07-2.14), 2.23 (2.01-2.48) for smoking, 1.98 (1.71-2.29) for obesity and 5.10 (3.18-8.18) for chronic hypertension. In stratified analysis the association of CVD with GDM was only seen among women with BMI 25, with an odds ratio of 2.39 (1.39-4.10), but only women with a BMI <30 accounted for this increased risk. Adjustment for post-pregnancy diabetes attenuated it somewhat to 1.99 (1.13-3.52).

    Conclusions: In the absence of other recognised cardiovascular risk factors, such as smoking, obesity or chronic hypertension, GDM is a useful marker of raised CVD risk among women with BMI between 25 and 29.

  • 19.
    Fadl, Helena
    et al.
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden.
    Magnuson, Anders
    Clinical Epidemiology and Biostatistics Unit, Örebro University Hospital.
    Östlund, Ingrid
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden.
    Montgomery, Scott
    Clinical Epidemiology and Biostatistics Unit, Örebro University Hospital, Sweden; Clinical Epidemiology Unit, Karolinska Institutet, Stockholm, Sweden; Department of Primary Care and Public Health, Charing Cross Hospital, Imperial College, London, UK.
    Hanson, Ulf
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden.
    Schwarcz, Erik
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden.
    Gestational diabetes mellitus is associated with later cardiovascular disease, particularly among overweight women: a Swedish population based case-control studyManuscript (preprint) (Other academic)
  • 20.
    Fadl, Helena
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital. Uppsala, Sweden; Gothenburg, Sweden; Lund, Sweden; Kullavik, Sweden; Stockholm, Sweden; Västerås, Sweden; Campbelltown, Australia.
    Patil, Snehal
    Örebro University, School of Medical Sciences. Uppsala, Sweden; Gothenburg, Sweden; Lund, Sweden; Kullavik, Sweden; Stockholm, Sweden; Västerås, Sweden; Campbelltown, Australia.
    Wikström, Anna-Karin
    Örebro, Sweden; Uppsala, Sweden; Gothenburg, Sweden; Lund, Sweden; Kullavik, Sweden; Stockholm, Sweden; Västerås, Sweden; Campbelltown, Australia.
    Jansson, Stefan P. O.
    Örebro University, School of Medical Sciences. Örebro University Hospital. Uppsala, Sweden; Gothenburg, Sweden; Lund, Sweden; Kullavik, Sweden; Stockholm, Sweden; Västerås, Sweden; Campbelltown, Australia.
    Sengpiel, Verena
    Örebro, Sweden; Uppsala, Sweden; Gothenburg, Sweden; Lund, Sweden; Kullavik, Sweden; Stockholm, Sweden; Västerås, Sweden; Campbelltown, Australia.
    Berntorp, Kerstin
    Örebro, Sweden; Uppsala, Sweden; Gothenburg, Sweden; Lund, Sweden; Kullavik, Sweden; Stockholm, Sweden; Västerås, Sweden; Campbelltown, Australia.
    Ryen, Linda
    Örebro University, School of Health Sciences. Örebro University Hospital. Uppsala, Sweden; Gothenburg, Sweden; Lund, Sweden; Kullavik, Sweden; Stockholm, Sweden; Västerås, Sweden; Campbelltown, Australia.
    Ahlsson, Fredrik
    Örebro, Sweden; Uppsala, Sweden; Gothenburg, Sweden; Lund, Sweden; Kullavik, Sweden; Stockholm, Sweden; Västerås, Sweden; Campbelltown, Australia.
    Lindholm, Elisabeth S.
    Örebro, Sweden; Uppsala, Sweden; Gothenburg, Sweden; Lund, Sweden; Kullavik, Sweden; Stockholm, Sweden; Västerås, Sweden; Campbelltown, Australia.
    Strevens, Helena
    Örebro, Sweden; Uppsala, Sweden; Gothenburg, Sweden; Lund, Sweden; Kullavik, Sweden; Stockholm, Sweden; Västerås, Sweden; Campbelltown, Australia.
    Wennerholm, Ulla-Britt
    Örebro, Sweden; Uppsala, Sweden; Gothenburg, Sweden; Lund, Sweden; Kullavik, Sweden; Stockholm, Sweden; Västerås, Sweden; Campbelltown, Australia.
    Persson, Martina
    Örebro, Sweden; Uppsala, Sweden; Gothenburg, Sweden; Lund, Sweden; Kullavik, Sweden; Stockholm, Sweden; Västerås, Sweden; Campbelltown, Australia.
    de Brun, Maryam
    Örebro University, School of Medical Sciences. Uppsala, Sweden; Gothenburg, Sweden; Lund, Sweden; Kullavik, Sweden; Stockholm, Sweden; Västerås, Sweden; Campbelltown, Australia.
    Montgomery, Scott
    Örebro University, School of Medical Sciences. Uppsala, Sweden; Gothenburg, Sweden; Lund, Sweden; Kullavik, Sweden; Stockholm, Sweden; Västerås, Sweden; Campbelltown, Australia.
    SIMMONS, DAVID
    Örebro, Sweden; Uppsala, Sweden; Gothenburg, Sweden; Lund, Sweden; Kullavik, Sweden; Stockholm, Sweden; Västerås, Sweden; Campbelltown, Australia.
    Association of GDM Risk Factors with Glucose at Diagnosis and Treatment in Sweden2022In: Diabetes, ISSN 0012-1797, E-ISSN 1939-327X, Vol. 71, no Supplement_1, article id 1039-PArticle in journal (Refereed)
  • 21.
    Fadl, Helena
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynaecology.
    Saeedi, Maryam
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology.
    Magnuson, Anders
    Clinical Epidemiology and Biostatistics, University Hospital Örebro, Örebro, Sweden.
    Patil, Snehal
    Örebro University, School of Medical Sciences.
    Simmons, David
    Örebro University, School of Medical Sciences. Macarthur Clinical School, Western Sydney University, Campbelltown, Australia.
    Schwarcz, Erik
    Department of Internal Medicine, Schoolof medical health and sciences, Örebro University Hospital, Örebro, Sweden.
    Berntorp, Kerstin
    Department of Endocrinology, Skåne University Hospital, Clinical Research Center Malmö, Lund University, Lund, Sweden.
    Jansson, Stefan P. O.
    Örebro University, School of Medical Sciences. Örebro University Hospital. University Health Care Research Center.
    Persson, Martina
    Department of Paediatrics, Sachsska Children’s and Youth hospital and Department of Clinical Science and Education, Karolinska Institute, Stockholm, Sweden.
    Storck-Lindholm, Elisabeth
    Department of Obstetrics and Gynaecology, Södersjukhuset, Stockholm, Sweden.
    Sengpiel, Verena
    Department of Obstetricsand Gynaecology, Sahlgrenska University Hospital, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Wennerholm, Ulla-Britt
    Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy,University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Ahlsson, Fredrik
    Department of Women’s and Children’s health, Uppsala University, Uppsala, Sweden.
    Wikström, Anna-Karin
    Women’s and Children’s Health, Uppsala university, Uppsala, Sweden.
    Strevens, Helena
    Department of Obstetrics and Gynaecology, Skåne University Hospital, Clinical Research Center Lund, Lund University, Lund, Sweden.
    Petersson, Kerstin
    Department of Clinical Sciences, Obstetrics and Gynaecology, Umeå University, Umeå, Sweden.
    Ryen, Linda
    Örebro University, School of Health Sciences. Center for Health Care Science.
    Hildén, Karin
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology.
    Ursing, Carina
    Department of Endocrinology, Södersjukhuset, Stockholm, Sweden.
    Montgomery, Scott
    Örebro University, School of Medical Sciences. Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, Örebro, Sweden; Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Department of Epidemiology and Public Health, University College London, London, UK.
    Changing diagnostic criteria for gestational diabetes (CDC4G) in Sweden: a stepped wedge cluster randomised controlled trial2023Conference paper (Other academic)
  • 22.
    Fadl, Helena
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynaecology.
    Saeedi, Maryam
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology.
    Montgomery, Scott
    Örebro University, School of Medical Sciences. Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, Örebro, Sweden; Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Department of Epidemiology and Public Health, University College London, London, UK.
    Magnuson, Anders
    Clinical Epidemiology and Biostatistics, University Hospital Örebro, Örebro, Sweden.
    Schwarcz, Erik
    Department of Internal Medicine, Schoolof medical health and sciences, Örebro University Hospital, Örebro, Sweden.
    Berntorp, Kerstin
    Department of Endocrinology, Skåne University Hospital, Clinical Research Center Malmö, Lund University, Lund, Sweden.
    Sengpiel, Verena
    Department of Obstetricsand Gynaecology, Sahlgrenska University Hospital, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Storck-Lindholm, Elisabeth
    Department of Obstetrics and Gynaecology, Södersjukhuset, Stockholm, Sweden.
    Strevens, Helena
    Department of Obstetrics and Gynaecology, Skåne University Hospital, Clinical Research Center Lund, Lund University, Lund, Sweden.
    Wikström, Anna-Karin
    Women’s and Children’s Health, Uppsala university, Uppsala, Sweden.
    Brismar-Wendel, Sophia
    Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital, Stockholm, Sweden.
    Persson, Martina
    Department of Paediatrics, Sachsska Children’s and Youth hospital and Department of Clinical Science and Education, Karolinska Institute, Stockholm, Sweden.
    Jansson, Stefan P. O.
    Örebro University, School of Medical Sciences. Örebro University Hospital. University Health Care Research Center.
    Ahlsson, Fredrik
    Department of Women’s and Children’s health, Uppsala University, Uppsala, Sweden.
    Ursing, Carina
    Department of Endocrinology, Södersjukhuset, Stockholm, Sweden.
    Ryen, Linda
    Örebro University, School of Health Sciences. Center for Health Care Science.
    Petersson, Kerstin
    Department of Clinical Sciences, Obstetrics and Gynaecology, Umeå University, Umeå, Sweden.
    Wennerholm, Ulla-Britt
    Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy,University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Hildén, Karin
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology.
    Simmons, David
    Örebro University, School of Medical Sciences. Macarthur Clinical School, Western Sydney University, Campbelltown, Australia.
    Changing diagnostic criteria for gestational diabetes in Sweden: a stepped wedge national cluster randomised controlled trial-the CDC4G study protocol2019In: BMC Pregnancy and Childbirth, ISSN 1471-2393, E-ISSN 1471-2393, Vol. 19, no 1, article id 398Article in journal (Refereed)
    Abstract [en]

    Background: The optimal criteria to diagnose gestational diabetes mellitus (GDM) remain contested. The Swedish National Board of Health introduced the 2013 WHO criteria in 2015 as a recommendation for initiation of treatment for hyperglycaemia during pregnancy. With variation in GDM screening and diagnostic practice across the country, it was agreed that the shift to new guidelines should be in a scientific and structured way. The aim of the Changing Diagnostic Criteria for Gestational Diabetes (CDC4G) in Sweden () is to evaluate the clinical and health economic impacts of changing diagnostic criteria for GDM in Sweden and to create a prospective cohort to compare the many long-term outcomes in mother and baby under the old and new diagnostic approaches.

    Methods: This is a stepped wedge cluster randomised controlled trial, comparing pregnancy outcomes before and after the switch in GDM criteria across 11 centres in a randomised manner. The trial includes all pregnant women screened for GDM across the participating centres during January-December 2018, approximately two thirds of all pregnancies in Sweden in a year. Women with pre-existing diabetes will be excluded. Data will be collected through the national Swedish Pregnancy register and for follow up studies other health registers will be included.

    Discussion: The stepped wedge RCT was chosen to be the best study design for evaluating the shift from old to new diagnostic criteria of GDM in Sweden. The national quality registers provide data on the whole pregnant population and gives a possibility for follow up studies of both mother and child. The health economic analysis from the study will give a solid evidence base for future changes in order to improve immediate pregnancy, as well as long term, outcomes for mother and child.

  • 23.
    Fadl, Helena
    et al.
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Maternal Health Care Unit, Primary Care, Örebro County, Örebro, Sweden; Department of Obstetrics and Gynecology, Örebro University Hospital, Örebro, Sweden.
    Östlund, Ingrid K. M.
    Department of Obstetrics and Gynecology, Örebro University Hospital, Örebro, Sweden.
    Hanson, Ulf
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Department of Women’s and Children’ Health, Uppsala University, Uppsala, Sweden.
    Outcomes of gestational diabetes in Sweden depending on country of birth2012In: Acta Obstetricia et Gynecologica Scandinavica, ISSN 0001-6349, E-ISSN 1600-0412, Vol. 91, no 11, p. 1326-1330Article in journal (Refereed)
    Abstract [en]

    Objective: To analyze maternal and neonatal outcomes for women with gestational diabetes mellitus (GDM) in Sweden, depending on country of birth (Nordic vs. non-Nordic women).

    Design: Population-based cohort study using the Swedish Medical Birth register.

    Setting: Data on pregnant women in Sweden with diagnosed GDM.

    Population: All singleton births to women with GDM between 1998 and 2007 (n = 8560).

    Methods: Logistic regression in an adjusted model to assess the risk of adverse maternal and neonatal outcomes. Chi-squared tests or Student's unpaired t-tests were used to analyze differences between maternal and fetal characteristics.

    Main outcome measures: Maternal and neonatal complications.

    Results: GDM incidence was higher at 2.0% among non-Nordic women, compared with 0.7% in the Nordic group. The non-Nordic women were older, had less chronic hypertensive disease, smoked less, and had lower BMI and shorter height. Preeclampsia was significantly lower in the non-Nordic group. The mean birthweight (3561 vs. 3698 g, p < 0.001) and the large-for-gestational age rate (11.7 vs. 17.5%, p < 0.001) were significantly lower in the non-Nordic group. Large-for-gestational age was dependent on maternal height [crude odds ratio 0.6 (0.5-0.7) and adjusted odds ratio 0.8 (0.6-0.9)].

    Conclusions: Non-Nordic women with GDM in Sweden have better obstetrical and neonatal outcomes than Nordic women. These results do not support the idea of inequality of health care. Large-for-gestational age as a diagnosis is highly dependent on maternal height, which raises the question of the need for individualized growth curves.

  • 24.
    Fadl, Helena
    et al.
    Örebro University Hospital. Department of Obstetrics and Gynaecology .
    Östlund, Ingrid
    Örebro University Hospital. Department of Obstetrics and Gynaecology .
    Nilsson, Kerstin
    Örebro University Hospital. Department of Clinical Medicine, Section of Obstetrics and Gynaecology.
    Hanson, U.
    Department of Woman’s and Children’s Health, Uppsala University, Uppsala, Sweden.
    Fasting capillary glucose as a screening test for gestational diabetes mellitus2007In: British Journal of Obstetrics and Gynecology, ISSN 1470-0328, E-ISSN 1471-0528, Vol. 114, no 3, p. 373-373Article in journal (Refereed)
  • 25.
    Fadl, Helena
    et al.
    Örebro University Hospital. Department of Obstetrics and Gynaecology .
    Östlund, Ingrid
    Örebro University Hospital. Department of Obstetrics and Gynaecology .
    Nilsson, Kerstin
    Örebro University Hospital. Department of Obstetrics and Gynaecology and Department of Clinical Medicine, Section of Obstetrics and Gynecology.
    Hanson, U
    Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden.
    Fasting capillary glucose as a screening test for gestational diabetes mellitus2006In: BJOG: an International Journal of Obstetrics and Gynaecology, ISSN 1470-0328, Vol. 113, no 9, p. 1067-71Article in journal (Refereed)
    Abstract [en]

    Objective: To evaluate fasting capillary glucose as a screening test for gestational diabetes mellitus (GDM) compared with traditional risk factors and repeated random capillary glucose measurements.

    Design: Cross-sectional, population-based study.

    Setting: Maternal Health Care Clinics in Orebro County, Sweden.

    Population: An unselected population of women without diabetes.

    Methods: Fasting capillary glucose levels were measured at gestational weeks 28-32. Random capillary glucose levels were measured four to six times during pregnancy. Traditional risk factors for GDM were registered. GDM was diagnosed using a 75-g oral glucose tolerance test.

    Main outcome measures: Sensitivity, specificity, likelihood ratios.

    Results: In 55 of 3616 women participating in the study, GDM was diagnosed before 34 weeks of gestation. For fasting capillary glucose cutoff values between 4.0 and 5.0 mmol/l, sensitivity was in the range between 87 and 47% and specificity between 51 and 96%. Using a combined screening model of traditional risk factors with fasting capillary glucose at various cutoff values increased the sensitivity only slightly compared with using fasting capillary glucose alone.

    Conclusion: In this Swedish, unselected, low-risk population, fasting capillary glucose measurements were found to be an acceptable and useful screening test for GDM.

  • 26.
    Fadl, Helena
    et al.
    Örebro University Hospital. Department of Obstetrics and Gynaecology.
    Östlund, Ingrid
    Örebro University Hospital. Department of Obstetrics and Gynaecology.
    Nilsson, Kerstin
    Örebro University Hospital. Department of Clinical Medicine, Section of Obstetrics and Gynaecology.
    Hanson, U.
    Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden.
    Fasting capillary glucose as a screening test for gestational diabetes mellitus - Author's reply2007In: BJOG: an International Journal of Obstetrics and Gynaecology, ISSN 1470-0328, Vol. 114, no 2, p. 238-239Article in journal (Refereed)
  • 27.
    Harreiter, Jürgen
    et al.
    Gender Medicine Unit, Division of Endocrinology and Metabolism, Department of Medicine III, Medical University of Vienna, Vienna, Austria.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynaecology.
    Kautzky-Willer, Alexandra
    Gender Medicine Unit, Division of Endocrinology and Metabolism, Department of Medicine III, Medical University of Vienna, Vienna, Austria; Gender Institute, Gars am Kamp, Austria.
    Simmons, David
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Macarthur Clinical School, Western Sydney University, Sydney, New South Wales, Australia.
    Do Women with Diabetes Need More Intensive Action for Cardiovascular Reduction than Men with Diabetes?2020In: Current Diabetes Reports, ISSN 1534-4827, E-ISSN 1539-0829, Vol. 20, no 11, article id 61Article, review/survey (Refereed)
    Abstract [en]

    Purpose of review: This narrative review makes the case for greater efforts to reduce cardiovascular disease (CVD) risk in women with diabetes.

    Recent findings: In a recent meta-analysis including five CVOTs of diabetes medications with 46,606 subjects, women (vs men) with type 2 diabetes had a higher relative risk for stroke (RR 1.28; 95% CI 1.09, 1.50) and heart failure (1.30; 1.21, 1.40). Prior studies found higher "within-gender" RR for CVD mortality in women with diabetes although men have an absolute higher risk. Women with prior gestational diabetes mellitus (GDM) have a 2-fold higher CVD risk than the background population. Worse CVD and CVD risk factor management in women, as well as lower female therapy adherence, contribute further to these disparities.

    Summary: The mechanism behind this excess risk includes biological, hormonal, socioeconomic, clinical, and behavioral factors that still require further investigation. The need for more intensive CVD reduction in women now includes more attention to screening for both incident diabetes and CVD risk factors among high-risk women.

  • 28.
    Harreiter, Jürgen
    et al.
    Medizinische Universität Wien, Wien, Österreich.
    Simmons, David
    Western Sydney University, Sydney, Australien.
    Immanuel, Jincy
    Western Sydney University, Sydney, Australien.
    Hague, Bill
    The University of Adelaide, Adelaide, Australien.
    Teede, Helena
    Monash University, Melbourne, Australien.
    Cheung, N. Wah
    Westmead Hospital, Sydney, Australien.
    Hibbert, Emily
    Nepean Hospital, Sydney, Australien.
    Nolan, Christopher
    Canberra Hospital and Australian National University, Canberra, Australien.
    Peek, Michael
    University of New South Wales, Sydney, Australien.
    Kiss, Herbert
    Medizinische Universität Wien, Wien, Österreich.
    Wong, Vincent
    Liverpool Hospital, Sydney, Australien.
    Flack, Jeff
    Western Sydney University, Sydney, Australien; Bankstown-Lidcombe Hospital, Sydney, Australien.
    Mclean, Mark
    Blacktown Hospital, Sydney, Australien.
    Sweeting, Arianne
    Royal Prince Alfred Hospital, Sydney, Australien.
    Gianatti, Emily
    Fiona Stanley Hospital, Perth, Australien.
    Mohan, Viswanathan
    Dr.Mohans Diabetes Specialities Centre, Chennai, Indien.
    Backman, Helena
    Örebro University Hospital. Örebro University, School of Health Sciences.
    Kautzky-Willer, Alexandra
    Medizinische Universität Wien, Wien, Österreich.
    Behandlung von früh diagnostiziertem Gestationsdiabetes mellitus vor der 20. Schwangerschaftswoche: [Treatment of early diagnosed Gestational Diabetes mellitus before the 20th Week of Pregnancy]2023In: Wiener Klinische Wochenschrift, ISSN 0043-5325, E-ISSN 1613-7671, Vol. 135, no Suppl. 7, p. S762-S762, article id 19Article in journal (Other academic)
    Abstract [de]

    Einleitung: Bei Diagnose eines Gestationsdiabetes (GDM) vor der 20.Schwangerschaftswoche (SSW) wird leitliniengemäß eine Therapie begonnen. Für diese Praxis liegt keine Evidenz vor, die eine Verbesserung der Gesundheit von Mutter oder Nachkommen bei GDM-Behandlung in der frühen Schwangerschaft belegt.

    Methoden: Frauen mit einem Risikofaktor für GDM wurden zwischen 4.−20.SSW bei Vorliegen einer GDM Diagnose nach WHO 2013 Kriterien randomisiert einer Behandlungsgruppe oder einer Kontrollgruppe zugeordnet. Die Behandlungs-gruppe erhielt sofortige GDM Behandlung, während die Kontrollgruppe je nach Ergebnissen eines erneuten oralen Glukosetoleranztests (OGTT) in der 24.−28.SSW eine verschobene oder keine Behandlung erhielt. Die Studie hatte drei primäre Endpunkte: eine Kombination ungünstiger neonataler Ereignisse (Geburt <37.SSW, Geburtstrauma, Geburtsgewicht ≥4500 g, RDS, Phototherapie, Totgeburt/neonataler Tod oder Schulterdystokie), schwangerschaftsbedingte Hypertonieerkrankungen (Präeklampsie, Eklampsie, gestationsbedingter Bluthochdruck) und neonatale fettfreie Körpermasse.

    Ergebnisse: Insgesamt wurden 802 Frauen randomisiert (406 Sofortbehandlung, 396 Kontrollgruppe). Die Erstvisite fand durchschnittlich in der 15,6 ± 2,5 SSW statt. Der neonatale Kombinationsendpunkt trat bei 94/378 Frauen (24,9 %) bei sofortiger Behandlung und bei 113/370 Frauen (30,5 %) in der Kontrollgruppe auf (adj. Risikounterschied −5,6 %;95 % KI,–10,1;−1,2, RR 0,82;0,68-0,98). Schwangerschaftsbedingter Bluthochdruck trat bei 40/378 Frauen (10,6 %) bei sofortiger Behandlung und bei 37/372 Frauen (9,9 %) in der Kontrollgruppe auf (0,7 %,95 % KI,–1,6;2,9, RR 1.08;0.85–1.38). Die fettfreie Körpermasse der Neugeborenen betrug 2,86 kg bei sofortiger Behandlung und 2,91 kg in der Kontrollgruppe (−0,04 kg; 95 % KI,–0,09;0,02). Untergruppenanalysen zeigten eine stärkere Wirkung der Intervention auf neonatale Ergebnisse bei Frauen mit höheren Blutzuckerwerten und bei OGTT Durchführung vor der 14.SSW.

    Schlussfolgerung: Die sofortige Behandlung von Gestationsdiabetes vor der 20.SSW führte zu einer geringeren Häufigkeit ungünstiger neonataler Ergebnisse im Vergleich zu späterem Behandlungsbeginn.

  • 29.
    Hildén, K.
    et al.
    Department of Obstetrics & Gynaecology, School of Medical Sciences, Örebro University, Örebro, Sweden.
    Hanson, U.
    School of Medical Sciences, Örebro University, Örebro, Sweden; Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
    Persson, M.
    Department of Medicine, Clinical Epidemiology Unit, Karolinska Universitetssjukhuset, Solna, Sweden.
    Magnuson, A.
    Örebro University, Örebro, Sweden.
    Simmons, David
    Örebro University, School of Medical Sciences. School of Medicine, Western Sydney University, Campbelltown, NSW, Australia.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics & Gynaecology.
    Gestational diabetes and adiposity are independent risk factors for perinatal outcomes: a population based cohort study in Sweden2019In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 36, no 2, p. 151-157Article in journal (Refereed)
    Abstract [en]

    AIMS: To evaluate the interaction effects of gestational diabetes (GDM) with obesity on perinatal outcomes.

    METHODS: A population-based cohort study in Sweden excluding women without pre-gestational diabetes with a singleton birth between 1998 and 2012. Logistic regression was performed to evaluate the potential independent associations of GDM and BMI with adverse perinatal outcomes as well as their interactions. Main outcome measures were malformations, stillbirths, perinatal mortality, low Apgar score, fetal distress, prematurity and Erb's palsy.

    RESULTS: ) had significantly increased risks of all outcomes including stillbirth 1.51 (1.40-1.62) to 2.85 (2.52-3.22) and perinatal mortality 1.49 (1.40-1.59) to 2.83 (2.54-3.15).

    CONCLUSIONS: There is no interaction effect between GDM and BMI for the studied outcomes. Higher BMI and GDM are major independent risk factors for most serious adverse perinatal outcomes. More effective pre-pregnancy and antenatal interventions are required to prevent serious adverse pregnancy outcomes among women with either GDM or high BMI.

  • 30.
    Hildén, Karin
    et al.
    Örebro University, School of Medical Sciences.
    Arntyr-Hellgren, Paulina
    Magnuson, Anders
    Hanson, Ulf
    Simmons, David
    Örebro University, School of Medical Sciences.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital.
    Born over 4500 g: the trends in birth trauma and mode of delivery in women with GDM and type 1 diabetes in Sweden between 1998-20122018Conference paper (Refereed)
    Abstract [en]

    Background: We have previously shown that during the years 1998-2012, the overall incidence of LGA and birthweight decreased in both women with and without GDM in Sweden, and unpublished preliminary results show that there is a converse trend among women with T1DM. The incidence of Erbs palsy also decreased in the GDM and background population, but remained unchanged for women with T1DM. Since macrosomia is one of the most prominent risk factors for Erb´s palsy and delivery complications, the aim of the study was to evaluate trends in incidence of Erb´s palsy and delivery mode in the macrosomic group defined as weight ≥4500g and we present here our preliminary results.

    Method: This is a cohort study in Sweden 1998-2012 , including singleton macrosomic (≥4500 g) births. Vaginal deliveries were selected for the analyses relating to Erb´s plasy. Poisson regression was used to evaluate trends per year in both the GDM, T1DM and the background population. Results were partly stratified on BMI, to be able to detect any group differences in trends. P-value of <0.05 was considered statistically significant.

    Results: In total there were 57 2015 macrosomic infants, of whom (n= 36 933, 64,6%) were delivered vaginally. Of these, only 2.1 % (n=798) were vaginally delivered by women with GDM, (1.4%) type 2 diabetes (0.1%) or T1DM (0.7%). The trend in Erb´s palsy decreased significantly in the background population at a rate of OR 0.954 (95% CI 0.936-0.973) per year. For women with GDM or T1DM there was no significant change in incidence of trends over these years for Erb´s palsy. As for Caesarean section (CS) there was a significant increase per year for GDM pregnancies (OR 1.028, 95% CI 1.007-1.049) and in the background population (1.018 95% CI 1.013-1.022). No change was seen for CS in pregnancies with T1DM.

    Conclusion: Even though the rates of LGA and birthweight have decreased in Sweden over this time period for women with GDM and the background population, we could not see a significant decrease in Erb´s palsy among women with vaginal births in either the GDM group or for women with T1DM in the macrosomic infants. However, a decrease was seen in the incidence of Erb´s palsy in the macrosomic babies in the background population. The rates of CS have significantly increased in the background population and for GDM pregnancies, but been stable for T1DM. We conclude that the disparity in risk of Erbs has grown over this time period. Further work is needed to ascertain whether this is due to the need for improved surveillance, a higher CS rate, and/or improved glycaemic management (or other factors).

  • 31.
    Hildén, Karin
    et al.
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology.
    Hanson, Ulf
    Örebro University, School of Health Sciences. Department of Obstetrics and Gynaecology, School of Health and Medical Sciences, Örebro University, Örebro, Sweden; Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden.
    Persson, M.
    Department of Clinical Epidemiology, Karolinska Institutet, Stockholm, Sweden.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology.
    Overweight and obesity: a remaining problem in women treated for severe gestational diabetes2016In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 33, no 8, p. 1045-1051Article in journal (Refereed)
    Abstract [en]

    Aim: To analyse the impact of overweight and obesity on the risk of adverse maternal outcomes and fetal macrosomia in pregnancies of women treated for severe gestational diabetes.

    Methods This was a population-based cohort study including all singleton pregnancies in Sweden without pre-existing diabetes in the period 1998-2012. Only mothers with an early- pregnancy BMI of ≥18.5 kg/m² were included. Logistic regression analysis was used to determine odds ratios with 95% CIs for maternal outcomes and fetal growth. Analyses were stratified by maternal gestational diabetes/non-gestational diabetes to investigate the impact of overweight/obesity in each group.

    Results: Of 1 249 908 singleton births, 13 057 were diagnosed with gestational diabetes (1.0%). Overweight/obesity had the same impact on the risks of caesarean section and fetal macrosomia in pregnancies with and without gestational diabetes, but the impact of maternal BMI on the risk of preeclampsia was less pronounced in women with gestational diabetes. Normal-weight women with gestational diabetes had an increased risk of caesarean section [odds ratio 1.26 (95% CI 1.16-1.37)], preeclampsia [odds ratio 2.03 (95% CI 1.71-2.41)] and large-for-gestational-age infants [odds ratio 2.25 (95% CI 2.06-2.46)]. Risks were similar in the overweight group without gestational diabetes, caesarean section [odds ratio 1.34 (1.33-1.36)], preeclampsia odds ratio [1.76 (95% CI 1.72-1.81)], large-for-gestational-age [odds ratio 1.76 (95% CI 1.74-1.79)].

    Conclusions: Maternal overweight and obesity is associated with similar increments in risks of adverse maternal outcomes and delivery of large-for-gestational-age infants in women with and without gestational diabetes. Obese women with gestational diabetes are defined as a high-risk group. Normal-weight women with gestational diabetes have similar risks of adverse outcomes to overweight women without gestational diabetes.

  • 32.
    Hildén, Karin
    et al.
    Örebro University, School of Medical Sciences. Department of Obstetrics & Gynaecology.
    Hanson, Ulf
    Department of Women’s and Children’s Health, Uppsala University, Sweden; School of Health and Medical Sciences, Örebro University, Örebro, Sweden.
    Persson, M.
    Department of Medicine, Clinical Epidemiology Unit, Karolinska Universitetssjukhuset Solna, Karolinska Institutet, Sweden.
    Magnuson, A.
    Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, Örebro, sweden.
    Simmons, David
    Örebro University, School of Medical Sciences. School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics & Gynaecology.
    Are gestational diabetes and adiposity independent risk factors for perinatal outcomes?: A population based cohort study in Sweden2018Manuscript (preprint) (Other academic)
  • 33.
    Hildén, Karin
    et al.
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology.
    Magnuson, A.
    Clinical Epidemiology and Biostatistics, Faculty of Medicine and Health, Örebro University, Örebro.
    Hanson, U.
    Faculty of Medicine and Health, Örebro University, Örebro.
    Simmons, David
    Örebro University, School of Medical Sciences. School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynaecology.
    Trends in pregnancy outcomes for women with gestational diabetes mellitus in Sweden 1998-2012: a nationwide cohort study2020In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 37, no 12, p. 2050-2057Article in journal (Refereed)
    Abstract [en]

    AIM: To assess whether incidence of maternal and neonatal outcomes for women with or without gestational diabetes mellitus (GDM) have changed over time.

    METHODS: Population-based cohort study in Sweden including all singleton pregnancies over the period 1998-2012. GDM was diagnosed following Diabetic Pregnancy Study Group 1991 criteria. Poisson regression or negative binomial regression was used to model yearly relative change in numbers of cases and incidence of the outcomes with 95% confidence intervals (CI), and yearly absolute change in birthweight z-score.

    RESULTS: The study included 1 455 667 pregnancies. The number of pregnancies increased over time and the overall prevalence of GDM was 1%. For women with GDM there was a significantly decreasing trend in incidence per year for large for gestational age (LGA) (0.986, 95% CI 0.975 to 0.996), birthweight z-score (-0.012, 95% CI -0.017 to -0.007) and birth trauma (0.937, 95% CI 0.907 to 0.968). The trend for small for gestational age (SGA) among women with GDM increased by an OR per year (1.016, 95% CI 1.002 to 1.029). No significant interaction tests for maternal characteristics were found. Trends in outcomes for women without diabetes were similar to those for women with GDM.

    CONCLUSIONS: This study shows that there were improvements in pregnancy outcomes for women with GDM between 1998 and 2012, although the incidence of SGA increased. Improvements followed similar trends in the background population. Inequalities in obstetric outcomes between women with GDM and those without have continued unchanged over 15 years, suggesting that new management strategies are required to reduce this gap.

  • 34.
    Hildén, Karin
    et al.
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Magnuson, A.
    Clinical Epidemiology and Biostatistics, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Montgomery, Scott
    Örebro University, School of Medical Sciences. Clinical Epidemiology and Biostatistics, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Clinical Epidemiology Division, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden.
    Schwarcz, E.
    Department of Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Hanson, U.
    Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden; Faculty of Medicine, Health Örebro University, Örebro, Sweden.
    Simmons, D.
    Faculty of Medicine, Health Örebro University, Örebro, Sweden; School of Medicine, Western Sydney University, Campbelltown, Australia.
    Backman, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynaecology.
    Previous pre-eclampsia, gestational diabetes mellitus and the risk of cardiovascular disease: A nested case-control study in Sweden2023In: British Journal of Obstetrics and Gynecology, ISSN 1470-0328, E-ISSN 1471-0528, Vol. 130, no 10, p. 1209-1216Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: Pre-eclampsia and gestational diabetes mellitus (GDM) are two common pregnancy complications that affect birth outcomes and are associated with a long-term risk of cardiovascular disease (CVD). The aims of this study were to investigate if the pre-eclampsia association with CVD is independent of GDM and modified by body mass index (BMI) or GDM. DESIGN: Case-control study.

    SETTING: Sweden.

    POPULATION: Cases were women with a first CVD event between 1991 and 2008 and a previous pregnancy who were matched with controls without CVD (1:5) by year of birth, age and region of birth. METHODS: Conditional logistic regression was used to evaluate the associations of GDM, pre-eclampsia and maternal BMI with CVD adjusted for potential confounders and effect modifications with interaction tests.

    MAIN OUTCOME MEASURES: CVD.

    RESULTS: There were 2639 cases and 13 310 controls with complete data. Pre-eclampsia and GDM were independent risk factors for CVD (adjusted odds ratio [aOR] 2.59, 95% CI 2.12-3.17 and aOR 1.47, 95% CI 1.04-2.09, respectively). After stratifying by maternal BMI, the adjusted association of pre-eclampsia with CVD did not differ notably between BMI groups: normal weight (aOR 2.65, 95% CI 1.90-3.69), overweight (aOR 2.67, 95% CI 1.52-4.68) and obesity (aOR 3.03, 95% CI 0.74-12.4). Similar findings were seen when stratifying on GDM/non-GDM.

    CONCLUSIONS: Pre-eclampsia and GDM are independent risk factors for later CVD and having both during pregnancy is a major risk factor for later CVD. The association between pre-eclampsia and CVD is not modified by BMI. Effective CVD preventive programs for high-risk women are urgently needed in order to improve women's long-term health.

  • 35.
    Hildén, Karin
    et al.
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology.
    Magnuson, A.
    Clinical Epidemiology and Biostatistics, Örebro University Hosptial, Örebro, Sweden.
    Montgomery, Scott
    Örebro University, School of Medical Sciences. Clinical Epidemiology Unit, Karolinska Institutet, Stockholm, Sweden.
    Schwarcz, E.
    Department of Medicine, School of Medical Sciences, Örebro University, Örebro, Sweden.
    Hanson, U.
    Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden; School of Medical Sciences, Örebro University, Örebro, Sweden .
    Simmons, David
    Örebro University, School of Medical Sciences. School of Medicine, Western Sydney University, Campbelltown New South Wales, Australia.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynaecology.
    Cardiovascular disease among women with previous preeclampsia and/or gestational diabetes mellitus: a national case control studyManuscript (preprint) (Other academic)
  • 36.
    Hildén, Karin
    et al.
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynaecology.
    Magnuson, Anders
    Clinical Epidemiology and Biostatistics, School of Health and Medical Sciences, Örebro University, Örebro, Sweden.
    Hanson, Ulf
    Clinical Epidemiology and Biostatistics, School of Health and Medical Sciences, Örebro University, Örebro, Sweden; Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden.
    Simmons, David
    Örebro University, School of Medical Sciences. School of Medicine, Western Sydney University, Campbelltown New South Wales, Australia.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynaecology.
    Trends in pregnancy outcomes for women with gestational diabetes mellitus in Sweden 1998-2012: a nationwide cohort studyManuscript (preprint) (Other academic)
  • 37.
    Kristensen, Karl
    et al.
    Department of Obstetrics and Gynecology, Skåne University Hospital, Malmö, Sweden; Department of Clinical Sciences Lund, Lund University, Lund, Sweden.
    Wangel, Anne-Marie
    Faculty of Health and Society, Department of Care Science, Malmö University, Malmö, Sweden.
    Katsarou, Anastasia
    Department of Endocrinology, Skåne University Hospital, Malmö, Sweden; Department of Clinical Sciences Malmö, Lund University, Lund, Sweden.
    Shaat, Nael
    Department of Endocrinology, Skåne University Hospital, Malmö, Sweden; Department of Clinical Sciences Malmö, Lund University, Lund, Sweden.
    Simmons, David
    Örebro University, School of Medical Sciences. Macarthur Clinical School, Western Sydney University, Campbelltown, Australia; Department of Obstetrics and Gynecology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynecology.
    Berntorp, Kerstin
    Department of Endocrinology, Skåne University Hospital, Malmö, Sweden; Department of Clinical Sciences Malmö, Lund University, Lund, Sweden.
    Diagnosis of Gestational Diabetes Mellitus with Point-of-Care Methods for Glucose versus Hospital Laboratory Method Using Isotope Dilution Gas Chromatography-Mass Spectrometry as Reference2020In: Journal of Diabetes Research, ISSN 2314-6745, E-ISSN 2314-6753, Vol. 2020, article id 7937403Article in journal (Refereed)
    Abstract [en]

    Background: In Sweden, both glucose analyzers in accredited laboratories and point-of-care glucose devices are used for gestational diabetes mellitus (GDM) diagnosis. The aim of this study was to compare the diagnostic performance of the HemoCue Glucose 201+ (HC201+) and RT (HC201RT) systems with that of the hospital central laboratory hexokinase method (CL) based on lyophilized citrate tubes, using the isotope dilution gas chromatography-mass spectrometry (ID GC-MS) as reference.

    Methods: A 75 g oral glucose tolerance test was performed on 135 women screened positive for GDM. Diagnosis was based on the World Health Organization 2013 diagnostic thresholds for fasting (n=135), 1 h (n=52), and 2 h (n=135) glucose measurements. Bland-Altman analysis and surveillance error grids were used to evaluate analytical and clinical accuracy.

    Results: Significantly more women were diagnosed with GDM by HC201+ (80%) and CL (80%) than with the reference (65%, P<0.001) based on fasting and/or 2 h thresholds, whereas the percentage diagnosed by HC201RT (60%) did not differ significantly from the reference. In Bland-Altman analysis, a positive bias was observed for HC201+ (4.2%) and CL (6.1%) and a negative bias for HC201RT (-1.8%). In the surveillance error grid, 95.9% of the HC201+ values were in the no-risk zone as compared to 98.1% for HC201RT and 97.5% for CL.

    Conclusions: A substantial positive bias was found for CL measurements resulting in overdiagnosis of GDM. Our findings suggest better performance of HC201RT than HC201+ in GDM diagnosis. The results may have possible implications for GDM diagnosis in Sweden and require further elucidation.

  • 38. Kuusela, Phila
    et al.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital.
    Wesström, Jan
    Lindgren, Peter
    Hagberg, Henrik
    Jacobsson, Bo
    Wennerholm, Ulla-Britt
    Valentin, Lil
    Intra- and Interrater reliability of Transvaginal Sonographic Measurements of Cervixal length2018Conference paper (Refereed)
  • 39.
    Kuusela, Pihla
    et al.
    Centre of Perinatal Medicine and Health, Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Södra Älvsborg Hospital, Borås, Sweden.
    Jacobsson, Bo
    Centre of Perinatal Medicine and Health, Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Hagberg, Henrik
    Centre of Perinatal Medicine and Health, Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynaecology.
    Lindgren, Peter
    Department of Clinical Science, Intervention and Technology, Karolinska Institute, Stockholm, Sweden; Center for Fetal Medicine, Karolinska University Hospital, Stockholm, Sweden.
    Wesström, Jan
    Center for Clinical Research Dalarna, Falun Hospital, Falun, Sweden.
    Wennerholm, Ulla-Britt
    Centre of Perinatal Medicine and Health, Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Obstetrics, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Valentin, Lil
    Department of Obstetrics and Gynaecology, Skåne University Hospital, Malmö, Sweden; Department of Medical Sciences Malmö, Lund University, Sweden.
    Second trimester transvaginal ultrasound measurement of cervical length for prediction of preterm birth: a blinded prospective multicentre diagnostic accuracy study2021In: British Journal of Obstetrics and Gynecology, ISSN 1470-0328, E-ISSN 1471-0528, Vol. 128, no 2, p. 195-206Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: To estimate the diagnostic performance of sonographic cervical length for prediction of preterm birth (PTB).

    DESIGN: Prospective observational multicentre study.

    SETTING: Seven Swedish ultrasound centres.

    SAMPLE: 11456 asymptomatic women with a singleton pregnancy.

    METHODS: Cervical length was measured with transvaginal ultrasound at 18 to 20 weeks (Cx1) and at 21 to 23 weeks (Cx2; optional). Staff and participants were blinded to results.

    MAIN OUTCOME MEASURES: Area under receiver operating characteristic curve (AUC), sensitivity, specificity, positive and negative predictive values (PPV, NPV), positive and negative likelihood ratios (LR+, LR-), number of false positive results per true positive result (FP/TP), number needed to screen to detect one PTB (NNS), prevalence of "short" cervix.

    RESULTS: Spontaneous PTB (sPTB) <33 weeks occurred in 56/11072 (0.5%) women in the Cx1 population (89% white ethnicity) and in 26/6288 (0.4%) in the Cx2 population (92% white ethnicity). The discriminative ability of shortest endocervical length was better the earlier the sPTB occurred and better at Cx2 than at Cx1 (AUC to predict sPTB <33 weeks 0.76 versus 0.65, difference in AUC 0.11, 95% CI 0.01 to 0.23). At Cx2, shortest endocervical length ≤25 mm (prevalence 4.4%) predicted sPTB <33 weeks with sensitivity 38.5% (10/26), specificity 95.8% (5998/6262), PPV 3.6% (10/274), NPV 99.7% (5988/6014), LR+ 9.1, LR- 0.64, 26 FP/TP, 629 NNS.

    CONCLUSION: Second trimester sonographic cervical length can identify women at high risk of sPTB. In a population of mainly white women and low prevalence of sPTB its diagnostic performance is at best moderate.

  • 40.
    Kuusela, Pihla
    et al.
    Sahlgrenska Academy, Centre of Perinatal Medicine and Health, Institute of Clinical Sciences, Gothenburg, Sweden; Södra Älvsborg Hospital, Department of Obstetrics and Gynecology, Borås, Sweden.
    Wennerholm, Ulla-Britt
    Sahlgrenska Academy, Centre of Perinatal Medicine and Health, Institute of Clinical Sciences, Gothenburg, Sweden; Region Vastra Gotaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Departement of Obstetrics and Gynecology.
    Wesström, Jan
    Centre for Clinical Research Dalarna, Falun Hospital, Falun, Sweden; Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
    Lindgren, Peter
    Center for fetal medicine, Karolinska University Hospital, Stockholm, Sweden.
    Hagberg, Henrik
    Sahlgrenska Academy, Centre of Perinatal Medicine and Health, Institute of Clinical Sciences, Gothenburg, Sweden; Region Vastra Gotaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden.
    Jacobsson, Bo
    Region Vastra Gotaland, Sahlgrenska University Hospital, Department of Obstetrics and Gynecology, Gothenburg, Sweden; Department of Genetics and Bioinformatics, Domain of Health Data and Digitalisation, Institute of Public Health, Oslo, Norway.
    Valentin, Lil
    Department of Medical Sciences Malmö, Lund University, Lund, Sweden; Skåne University Hospital, Department of Obstetrics and Gynecology, Malmö, Sweden.
    Second trimester cervical length measurements with transvaginal ultrasound: a prospective observational agreement and reliability study2020In: Acta Obstetricia et Gynecologica Scandinavica, ISSN 0001-6349, E-ISSN 1600-0412, Vol. 99, no 11, p. 1476-1485Article in journal (Refereed)
    Abstract [en]

    INTRODUCTION: Universal screening for preterm delivery by adding transvaginal ultrasound measurement of cervical length to routine second trimester ultrasound has been proposed. The aim is to estimate inter- and intra-observer agreement and reliability of second trimester transvaginal ultrasound measurements of cervical length performed by specially trained midwife sonographers.

    MATERIAL AND METHODS: This is a prospective reliability and agreement study performed in seven Swedish ultrasound centers. In total, 18 midwife sonographers specially trained to perform ultrasound measurements of cervical length and 286 women in the second trimester were included. In each center two midwife sonographers measured cervical length a few minutes apart in the same woman, the number of women examined per examiner pair varying between 24 and 30 (LIVE study). Sixteen midwife sonographers measured cervical length twice ≥2 months apart on 93 video-clips (CLIPS study). The main outcome measures were mean difference, limits of agreement, intra-class correlation coefficient, intra-individual standard deviation, repeatability, Cohen´s kappa, and Fleiss kappa.

    RESULTS: The limits of agreement and intra-class correlation coefficient of the best examiner pair in the LIVE study were -4.06 to 4.72 mm and 0.91, those of the poorest were -11.11 to 11.39 mm and 0.31. In the CLIPS study, median (range) intra-individual standard deviation was 2.14 mm (1.40 to 3.46), repeatability 5.93 mm (3.88 to 9.58), intra-class correlation coefficient 0.84 (0.66 to 0.94). Median (range) inter-observer agreement for cervical length ≤25 mm in the CLIPS study was 94.6% (84.9% to 98.9%) and Cohen´s kappa 0.56 (0.12 to 0.92), median (range) intra-observer agreement was 95.2% (87.1% to 98.9%) and Cohen´s kappa 0.68 (0.27 to 0.93).

    CONCLUSIONS: Agreement and reliability of cervical length measurements differed substantially between examiner pairs and examiners. If cervical length measurements are used to guide management there is potential for both over- and under-treatment. Uniform training and rigorous supervision and quality control are advised.

  • 41.
    Millbourn, C.
    et al.
    Department of Medicine Huddinge, Unit of Infectious Diseases, Karolinska Institutet, Stockholm, Sweden; Dept of Infectious Diseases, I73, Karolinska University Hospital, Stockholm, Sweden.
    Lybeck, Charlotte
    Örebro University, School of Medical Sciences. Dept of Infectious Diseases, Faculty of Health and Medical Sciences, Örebro University, Örebro, Sweden.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Dept of Obstetrics and Gynecology, Örebro University Hospital, Örebro, Sweden.
    Fredlund, Hans
    Dept Clin Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Lindahl, K.
    Department of Medicine Huddinge, Unit of Infectious Diseases, Karolinska Institutet, Stockholm, Sweden; Dept of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.
    Duberg, Ann-Sofi
    Örebro University, School of Medical Sciences. Dept of Infectious Diseases, Faculty of Health and Medical Sciences, Örebro University, Örebro, Sweden.
    Screening for HCV in pregnant women and their partners2017In: Journal of Hepatology, ISSN 0168-8278, E-ISSN 1600-0641, Vol. 66, no 1, p. S404-S405Article in journal (Refereed)
  • 42.
    Millbourn, Charlotta
    et al.
    Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden; Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Huddinge, Sweden; Department of Infectious Diseases, Danderyd Hospital, Stockholm, Sweden.
    Lybeck, Charlotte
    Örebro University, School of Medical Sciences. Department of Infectious Diseases.
    Einberg, Afrodite Psaros
    Department of Clinical Science, Intervention and Technology, CLINTEC, Stockholm, Sweden; Department of Pediatrics, Karolinska University Hospital, Stockholm, Sweden.
    Nordin, Margareta
    Department of Clinical Microbiology, Karolinska University Hospital, Stockholm, Sweden.
    Lindh, Gudrun
    Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden.
    Hökeberg, Ingegerd
    Department of Communicable Disease Prevention and Control, Stockholm County Council, Stockholm, Sweden.
    Fredlund, Hans
    Department of Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Fischler, Björn
    Department of Clinical Science, Intervention and Technology, CLINTEC, Stockholm, Sweden; Department of Pediatrics, Karolinska University Hospital, Stockholm, Sweden.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynecology.
    Duberg, Ann-Sofi
    Örebro University, School of Medical Sciences. Department of Infectious Diseases.
    Lindahl, Karin
    Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden; Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Huddinge, Sweden.
    Anti-HCV prevalence and risk factor-based screening for hepatitis C in pregnant women and their partners in Sweden2020In: Infectious Diseases, ISSN 2374-4235, E-ISSN 2374-4243, Vol. 52, no 11, p. 776-785Article in journal (Refereed)
    Abstract [en]

    Background: The hepatitis C virus (HCV) prevalence in Sweden is estimated to be <0.5%, but unclear in pregnant women. The dominating route of transmission is drug use (DU), blood transfusions constituted a risk before 1992. The aim was to examine the anti-HCV prevalence and risk factors for HCV among pregnant women and their partners to evaluate screening strategies.

    Methods: Pregnant women and partners in Örebro County and in southern Stockholm were offered HCV-screening when visiting an antenatal clinic in 2013-2016, and completed a questionnaire concerning the country of birth, knowledge of HCV-status and HCV risk factors.

    Results: In Örebro 2,827 pregnant women and 707 partners, and in Stockholm 1,281 pregnant women and 320 partners participated. Anti-HCV was positive in 34 (0.7%) (25 pregnant women) and the associated risk factors were DU (n = 27), partner with HCV (n = 24) and not born in Sweden (n = 8). HCV RNA was positive in 23 (0.4%), 4 previously unknown and 10 who had been lost to follow-up. The most effective risk factor-based screening model for pregnant women included DU, blood transfusions, born in high prevalence country, partner with HCV, resulting in 538 (13%) pregnant women tested with 96% sensitivity, 87% specificity.

    Conclusions: In this study of expecting parents in two Swedish regions, the anti-HCV prevalence was 0.7% and 0.4% were viraemic, of which about 60% were previously unknown or lost to follow-up. Awaiting more studies, including cost-benefit analysis evaluating universal screening, we recommend this improved risk factor-based screening model to identify HCV-infected individuals who need follow-up and therapy.

  • 43.
    Nilvér, Helena
    et al.
    Institute of Health and Care Sciences, Sahlgrenska Akademy, University of Gothenbourg, Gothenbourg, Sweden.
    Wessberg, Anna
    Institute of Health and Care Sciences, Sahlgrenska Akademy, University of Gothenbourg, Gothenbourg, Sweden; Department of Obstetrics, Sahlgrenska University Hospital, Gothenbourg, Sweden.
    Dencker, Anna
    Institute of Health and Care Sciences, Sahlgrenska Akademy, University of Gothenbourg, Gothenbourg, Sweden.
    Hagberg, Henrik
    Department of Obstetrics, Sahlgrenska University Hospital, Gothenbourg, Sweden; Centre of Perinatal Medicine & Health, Institute of Clinical Sciences, Salgrenska Akademy, Göteborgs Universitet, Gothenbourg, Sweden.
    Wennerholm, Ulla-Britt
    Department of Obstetrics, Sahlgrenska University Hospital, Gothenbourg, Sweden; Centre of Perinatal Medicine & Health, Institute of Clinical Sciences, Salgrenska Akademy, Göteborgs Universitet, Gothenbourg, Sweden.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynaecology.
    Wesström, Jan
    Centre for Clinical Research, Department of Women's Health, Dalarna County Council, Falun, Sweden.
    Sengpiel, Verena
    Department of Obstetrics, Sahlgrenska University Hospital, Gothenbourg, Sweden; Centre of Perinatal Medicine & Health, Institute of Clinical Sciences, Salgrenska Akademy, Göteborgs Universitet, Gothenbourg, Sweden.
    Lundgren, Ingela
    Institute of Health and Care Sciences, Sahlgrenska Akademy, University of Gothenbourg, Gothenbourg, Sweden; Department of Obstetrics, Sahlgrenska University Hospital, Gothenbourg, Sweden.
    Bergh, Christina
    Department of Reproductive Medicine, Sahlgrenska University Hospital, Gothenbourg, Sweden.
    Wikström, Anna-Karin
    Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
    Saltvedt, Sissel
    Department of Obstetrics and Gynaecology, Karolinska University Hospital, Stockholm, Sweden; Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.
    Elden, Helen
    Institute of Health and Care Sciences, Sahlgrenska Akademy, University of Gothenbourg, Gothenbourg, Sweden; Department of Obstetrics, Sahlgrenska University Hospital, Gothenbourg, Sweden.
    Women's childbirth experiences in the Swedish Post-term Induction Study (SWEPIS): a multicentre, randomised, controlled trial2021In: BMJ Open, E-ISSN 2044-6055, Vol. 11, no 4, article id e042340Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: To compare childbirth experiences in women randomly assigned to either induction of labour at 41 weeks or to expectant management until 42 weeks, in the Swedish Post-term Induction Study.

    DESIGN: A register-based, multicentre, randomised, controlled, superiority trial.

    SETTING: Women were recruited at 14 hospitals in Sweden, 2016-2018.

    PARTICIPANTS: Women with an uncomplicated singleton pregnancy were recruited at 41 gestational weeks.

    INTERVENTIONS: The women were randomly assigned to induction of labour at 41 weeks (induction group, n=1381) or expectant management until 42 weeks (expectant management group, n=1379).

    OUTCOME MEASURES: As main outcome, women's childbirth experiences were measured using the Childbirth Experience Questionnaire version 2 (CEQ2), in 656 women, 3 months after the birth at three hospitals. As exploratory outcome, overall childbirth experience was measured in 1457 women using a Visual Analogue Scale (VAS 1-10) within 3 days after delivery at the remaining eleven hospitals.

    RESULTS: The total response rate was 77% (2113/2760). There were no significant differences in childbirth experience measured with CEQ2 between the groups (induction group, n=354; expectant management group, n=302) in the subscales: own capacity (2.8 vs 2.7, p=0.09), perceived safety (3.3 vs 3.2, p=0.06) and professional support (3.6 vs 3.5, p=0.38) or in the total CEQ2 score (3.3 vs 3.2, p=0.07), respectively. Women in the induction group scored higher in the subscale participation (3.6 vs 3.4, p=0.02), although with a small effect size (0.19). No significant difference was observed in overall childbirth experience according to VAS (8.0 (n=735) vs 8.1 (n=735), p=0.22). 

    CONCLUSIONS: There were no differences in childbirth experience, according to CEQ2 or overall childbirth experience assessed with VAS, between women randomly assigned to induction of labour at 41 weeks or expectant management until 42 weeks. Overall, women rated their childbirth experiences high.

    TRIAL REGISTRATION NUMBER: ISRCTN26113652.

  • 44.
    Persson, M.
    et al.
    Clinical Epidemiological Unit, Department of Medicine, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden.
    Fadl, Helena
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Department of Obstetrics and Gynecology, School of Health and Medical Sciences, Örebro University, Örebro, Sweden.
    Perinatal outcome in relation to fetal sex in offspring to mothers with pre-gestational and gestational diabetes-a population-based study2014In: Diabetic Medicine, ISSN 0742-3071, E-ISSN 1464-5491, Vol. 31, no 9, p. 1047-1054Article in journal (Refereed)
    Abstract [en]

    Aim: The objective of the present study was to investigate if perinatal outcome differs with fetal sex in pregnancies with maternal Type 1 diabetes, Type 2 diabetes or gestational diabetes.

    Methods: This was a population-based cohort study, with data from the Medical Birth Registry in Sweden throughout the period 1998-2007. Singleton pregnancies with maternal Type 1 diabetes (n = 4092), Type 2 diabetes (n = 412) and gestational diabetes (n = 8602) were identified based on the International Classification of Diseases, 10th edition code. For comparison, 905 565 pregnancies without diabetes were included. The primary outcome was a composite outcome, consisting of any of the following diagnoses: perinatal mortality rate, major malformation, preterm delivery, acute respiratory disorders and neonatal hypoglycaemia. Logistic regression was used to obtain odds ratios for adverse outcomes in male offspring within the diabetic and reference cohorts, respectively.

    Results: In pregnancies with diabetes, maternal characteristics did not differ with fetal sex, except for a higher rate of Caesarean delivery in male offspring of women with Type 1 diabetes. Male infants to mothers with Type 1 diabetes and gestational diabetes had significantly increased odds of respiratory disorders [adjusted odds ratio (confidence interval) Type 1 diabetes: 1.50 (1.12-2.02); gestational diabetes: 1.81 (1.27-2.57)]. Male infants to mothers with gestational diabetes also had significantly increased odds of major malformations [adjusted odds ratio: 1.44 (1.07-1.93)]. In offspring of mothers with Type 2 diabetes, odds ratios of most outcomes were higher in male infants; however, not significantly different from female infants. In pregnancies without diabetes, male infants had significantly higher odds of all adverse outcomes, except perinatal mortality rate.

    Conclusion: The risk of adverse perinatal outcome in offspring of mothers with Type 1 diabetes and gestational diabetes did not differ by sex, except for a higher risk in male infants for respiratory disorders. The risk of major malformations was also significantly increased in male offspring to mothers with gestational diabetes. In offspring of mothers with Type 2 diabetes, no significant differences between sexes were found.

  • 45.
    Persson, Martina
    et al.
    Karolinska Institute, Stockholm, Sweden.
    Fadl, Helena
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden.
    Hanson, Ulf
    Uppsala University, Uppsala, Sweden.
    Pasupathy, Dharmintra
    Kings College London, London, England.
    Disproportionate Body Composition and Neonatal Outcome in Offspring of Mothers With and Without Gestational Diabetes Mellitus2013In: Diabetes Care, ISSN 0149-5992, E-ISSN 1935-5548, Vol. 36, no 11, p. 3543-3548Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: High birth weight is a risk factor for neonatal complications. It is not known if the risk differs with body proportionality. The primary aim of this study was to determine the risk of adverse pregnancy outcome in relation to body proportionality in large-for-gestational-age (LGA) infants stratified by maternal gestational diabetes mellitus (GDM).

    RESEARCH DESIGN AND METHODS: Population-based study of all LGA (birth weight [BW] >90th percentile) infants born to women with GDM (n = 1,547) in 1998-2007. The reference group comprised LGA infants (n = 83,493) born to mothers without diabetes. Data were obtained from the Swedish Birth Registry. Infants were categorized as proportionate (P-LGA) if ponderal index (PI) (BW in grams/length in cm(3)) was 90th percentile and as disproportionate (D-LGA) if PI >90th percentile. The primary outcome was a composite morbidity: Apgar score 0-3 at 5 min, birth trauma, respiratory disorders, hypoglycemia, or hyperbilirubinemia. Logistic regression analysis was used to obtain odds ratios (ORs) for adverse outcomes.

    RESULTS: The risk of composite neonatal morbidity was increased in GDM pregnancies versus control subjects but comparable between P- and D-LGA in both groups. D-LGA infants born to mothers without diabetes had significantly increased risk of birth trauma (OR 1.19 [95% CI 1.09-1.30]) and hypoglycemia (1.23 [1.11-1.37]). D-LGA infants in both groups had significantly increased odds of Cesarean section.

    CONCLUSIONS: The risk of composite neonatal morbidity is significantly increased in GDM offspring. In pregnancies both with and without GDM, the risk of composite neonatal morbidity is comparable between P- and D-LGA.

  • 46.
    Rönnberg, AnnKristin
    et al.
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Department of Obstetrics & Gynaecology, Örebro University Hospital, Örebro, Sweden.
    Östlund, Ingrid
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Örebro University Hospital. Department of Obstetrics and Gynaecology, Örebro University Hospital, Örebro, Sweden .
    Fadl, Helena
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Department of Obstetrics & Gynaecology, Örebro University Hospital, Örebro, Sweden.
    Gottvall, T.
    Department of Obstetrics and Gynaecology, Linköping University Hospital, Linköping, Sweden .
    Nilsson, Kerstin
    Örebro University, School of Medicine, Örebro University, Sweden. Department of Obstetrics & Gynaecology, Örebro University Hospital, Örebro, Sweden.
    Intervention during pregnancy to reduce excessive gestational weight gain: a randomised controlled trial2015In: British Journal of Obstetrics and Gynecology, ISSN 1470-0328, E-ISSN 1471-0528, Vol. 122, no 4, p. 537-544Article in journal (Refereed)
    Abstract [en]

    Objective: To evaluate if a feasible, low-cost intervention could decrease the percentage of women gaining weight above the Institute of Medicine (IOM) recommendations on gestational weight gain (GWG) compared with standard maternity care.

    Design: A randomised controlled interventional design.

    Setting: Antenatal clinics (n=14) in orebro county, Sweden, participated.

    Population: Healthy women with a body mass index (BMI) 19kg/m(2), age 18years and adequate knowledge of Swedish language who signed in for maternity care at 16weeks of gestation.

    Methods: Standard care was compared with a composite intervention consisting of education on recommended GWG according to IOM, application of personalised weight graph, formalised prescription of exercise and regular monitoring of GWG at every antenatal visit.

    Outcome: The proportion of women gaining weight above IOM guidelines (1990) and mean GWG (kg) was compared between groups.

    Results: In all, 445 women were randomised and 374 women remained for analysis after delivery. A majority of the women analysed were normal weight (72%). The intervention reduced the proportion of women who exceeded the IOM guidelines (41.1% versus 50.0%). The reduction was, however, not statistically significant (P=0.086). Mean GWG was significantly lower among women receiving the intervention, 14.2kg (SD 4.4) versus 15.3kg (SD 5.4) in the standard care group (P=0.029).

    Conclusions: The low-cost intervention programme tested did significantly reduce the mean GWG but the proportion of women who exceeded the IOM recommendations for GWG was not significantly lower. ClinicalTrials.gov Id NCT00451425

  • 47.
    Saeedi, Maryam
    et al.
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynecology.
    Cao, Yang
    Örebro University, School of Medical Sciences. Örebro University Hospital.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynecology.
    Gustafson, Hanne
    Department of Geriatrics, Örebro University Hospital, Region Örebro County, Sweden.
    Simmons, David
    Örebro University, School of Medical Sciences. Macarthur Clinical School, Western Sydney University, Campbelltown, Australia.
    Increasing prevalence of Gestational Diabetes Mellitus when implementing the IADPSG criteria: a systematic review and meta-analysis2021In: Diabetes Research and Clinical Practice, ISSN 0168-8227, E-ISSN 1872-8227, Vol. 172, article id 108642Article, review/survey (Refereed)
    Abstract [en]

    AIMS: Quantify the proportional increase in gestational diabetes (GDM) prevalence when implementing the new International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria compared to prior GDM criteria, and to assess risk factors that might affect the change in prevalence.

    METHODS: A systematic review and meta-analysis was performed of cohort and cross-sectional studies between January 1, 2010 to December 31, 2018 among pregnant women with GDM using IADPSG criteria compared to, and stratified by, old GDM criteria. Web of science, PubMed, EMBASE, Cochrane, Open Grey and Grey literature reports were included. The relative risk for each study was calculated. Subgroup analyses were performed by maternal age, body mass index, study design, country of publication, screening method, sampling method and data stratified according to diagnostic criteria.

    RESULTS: Thirty-one cohort and cross-sectional studies with 136 705 women were included. Implementing the IADPSG criteria was associated with a 75% (RR 1.75, 95% CI 1.53-2.01) increase in number of women with GDM with evidence of heterogeneity CONCLUSIONS: The IADPSG criteria increase the prevalence of GDM, but allow movement towards more homogeneity. More studies are needed of the benefits, harms, psychological effects and health costs of implementing the IADPSG criteria.

  • 48.
    Saeedi, Maryam
    et al.
    Örebro university hospital, Örebro, Sweden.
    Hanson, U.
    Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and GynaecologyUmeå University, Umeå, Sweden.
    Evaluation of screening methods for Gestational diabetes mellitus in Sweden2017In: 49th Annual Meeting of the Diabetic Pregnancy Study Group: Abstract book, 2017, p. 79-80Conference paper (Other academic)
    Abstract [en]

    Introduction: The Swedish National Board of Health and Welfare (SNBHW) adopted the IADPSG criteria in 2015. However these criteria have not been implemented by the healthcare regions. In this cross-sectional, population-based study we evaluated the test characteristics of current screening methods in Sweden (risk factors or 2 hour OGTT) and different values of fasting blood glucose as indicators to perform an oral glucose tolerance test for diagnosing GDM. GDM is based on the IADPSG criteria (1.75 odds ratio (OR)) and HAPO data of 2.0 OR for adverse pregnancy outcomes.

    Method: Between 1994-1996 all pregnant women (n= 3616) in Örebro county were offered a 75 g oral glucose tolerance test with determination of fasting capillary blood glucose and 2-hour capillary blood glucose was used to diagnose GDM. Random blood glucose was measured four to six times during pregnancy. Data on traditional risk factors and BMI were registered during the maternal healthcare visits.

    Results: 15.5% women met the IDPSG criteria (1.75 OR) based on only two values in the OGTT, and 9.0% were diagnosed if using an OR of 2.0. Current screening methods in Sweden showed 33 % and 39 % sensitivity when using the IADPSG criteria and HAPO data of 2.0 OR, respectively. A fasting cut-off value of 4.8 mmol/l when using the IADPSG criteria (1.75 OR) showed 92 % sensitivity, 95 % specificity and occurred in 19% of the patients. A fasting cut-off value of 5.1 mmol/l when using the HAPO data of 2.0 OR showed 92 % sensitivity, 98 % specificity and occurred in 10% of the patients.

    Conclusion: Current screening methods for GDM screening in Sweden is poorly predictive of GDM according to the IADPSG criteria (1.75 OR) and HAPO data (2.0 OR), but fasting glucose showed good test characteristics and results in a lower rate of OGTTs.

  • 49.
    Saeedi, Maryam
    et al.
    Örebro University hospital, Örebro, Sweden.
    Hanson, Ulf
    Department of Women's and Children's health, Uppsala University, Uppsala, Sweden; Department of Obstetrics and Gynecology, School of medical health and sciences, Örebro University Hospital, Örebro, Sweden.
    Simmons, David
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynecology, School of medical health and sciences, Örebro University Hospital, Örebro, Sweden; Macarthur Clinical School, Western Sydney University, Campbelltown, Australia.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Obstetrics and Gynecology.
    Characteristics of different risk factors and fasting plasma glucose for identifying GDM when using IADPSG criteria: a cross-sectional study2018In: BMC Pregnancy and Childbirth, ISSN 1471-2393, E-ISSN 1471-2393, Vol. 18, no 1, article id 225Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: The Swedish National Board of Health and Welfare (SNBHW) recommended the new diagnostic criteria for GDM based upon Hyperglycaemia and Adverse Pregnancy Outcomes (HAPO) study thresholds. Due to limited knowledge base, no recommendations were made on GDM screening. The aim of this study is to evaluate test characteristics of risk factors and fasting blood glucose as screening tests for diagnosing GDM using diagnostic thresholds based upon HAPO study 1.75/2.0 (model I/II respectively) odds ratio for adverse pregnancy outcomes.

    METHODS: This cross-sectional, population-based study included all pregnant women who attended maternal health care in Örebro County, Sweden between the years 1994-96. A 75 g OGTT with capillary fasting and 2-h blood glucose was offered to all pregnant women at week 28-32. Risk factors and repeated random glucose samples were collected. Sensitivity, specificity and predictive values of blood glucose were calculated.

    RESULTS: Prevalence of GDM was 11.7% with model I and 7.2% with the model II criteria. Risk factors showed 28%, (95% CI 24-32) and 31%, (95% CI 25-37) sensitivity for model I and II respectively. A fasting cut off ≥4.8 mmol/l occurred in 24% of women with 91%, (95% CI 88-94) sensitivity and 85%, (95% CI 83-86) specificity using model I while a fasting cut off ≥5.0 mmol/l occurred in 14% with 91%, (95% CI 87-94) sensitivity and 92%, (95% CI 91-93) specificity using model II.

    CONCLUSION: Risk factor screening for GDM was found to be poorly predictive of GDM but fasting glucose of 4.8-5.0 mmol/l showed good test characteristics irrespective of diagnostic model and results in a low rate of OGTTs.

  • 50.
    Saeedi, Maryam
    et al.
    Örebro University, School of Medical Sciences.
    Simmons, David
    Örebro University, School of Medical Sciences.
    Magnuson, Anders
    Montgomery, Scott
    Örebro University, School of Medical Sciences.
    Fadl, Helena
    Örebro University, School of Medical Sciences. Örebro University Hospital.
    The CDC4G trial: Impact of Changing Diagnostic Criteria for Gestational diabetes in Sweden – a stepped wedge national cluster randomised controlled trial-study protocol2018Conference paper (Refereed)
    Abstract [en]

    Introduction: In 2013 WHO recommended new criteria for GDM, defined as ≥5.1, ≥10.0 and/or ≥8.5 mmol/l fasting, 1 hour and/or 2 hour cut offs, which the Swedish National Board of Health adopted. With the current variation in GDM screening/diagnostic practice across Sweden and the debate over the criteria, we have established a stepped wedge cluster randomised controlled trial (SW-CRCT) to move towards a unified approach to GDM management. The objectives for the Changing Diagnostic Criteria for Gestational diabetes in Sweden (CDC4G) trial include: (1) To compare the rates of adverse neonatal and maternal outcomes before and after the change in GDM diagnostic criteria (2) To compare the health costs before and after the change and assess the net cost/saving (3)To compare the adverse outcomes and health costs using the new WHO criteria (75% excess risk) and the criteria based upon the 100% excess risk of neonatal adverse outcomes; using the national pregnancy register where all data needed is registered from the medical journals. The aim of this study is to describe the development of the study and the associated key issues.

    Methods: The CDC4G study is a national prospective, unblinded, SW-CRCT of the switch from pre-existing Swedish diagnostic criteria to the WHO 2013 criteria for GDM. Each participating centre constitutes one cluster, in which the patients undergo screening for GDM following their usual approach. The time of switch to the new criteria is randomized and subsequently rolled out until all clusters (centres) have received the intervention (introduction of the new GDM regimens) during 2018. All women treated in the participating clusters (including within primary care and hospitals) will be included in the study. Women with preexisting diabetes and overt diabetes are excluded. The key issues were identification of primary outcome, recruitment of sites and undertaking the power calculation.The study is approved by the Uppsala –Örebro regional ethics board, Dnr: 2016/487.

    Result: Identification of outcomes: As many women with GDM are not identified in the pre-switch period, measures that could be influenced by knowing the diagnosis (eg screening for neonatal hypoglycaemia) were excluded. The measure also needed to be frequent enough to have a large enough absolute reduction to be detected in the total obstetric population. As LGA is common (10% total population, 20% in GDM), it was decided that LGA should be primary outcome. Secondary maternal and neonate outcomes and health economic outcomes will also be evaluated. Recruitment of sites: Regions/clinics adopted the same protocols and hence were taken as ‘clusters’. There are 21 regions in Sweden and 38 clinics with annual births ranging between 540 and 10 200 births. Stockholm regions overlap so were taken as one cluster (5 clinics) . Overall 11/21 regions with 67000 births per annum agreed to participate. Annual births in Sweden is 95-100 000/year. Power calculation: With 11 clinics (clusters) participating and an intra cluster correlation of 0.0026 a minimum sample size of 47916 pregnant women (23958 before change and 23958 after change of the new GDM criteria) have 90% statistical power to detect a risk reduction of LGA by 1.5% on a population level (from 10% to 8.5%). The power calculation incorporates consideration of the varying sizes in cluster.

    Discussion: Establishing a national randomised controlled trial to evaluate the impact of the WHO 2013 criteria raised several challenges, which have now been addressed. The trial has commenced and final results of the study will be analyzed and disseminated in 2019 (www.cdc4g.com).

    Trial registration CDC4G is listed on the ISRCTN registry with study ID ISRCTN41918550 (15/12/2017).

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