To Örebro University

OBJECTIVE: To investigate the association of timing of commencing glucose management with glycemia, glycemic variability, and pregnancy outcomes among women with early gestational diabetes mellitus (GDM).

RESEARCH DESIGN AND METHODS: In this substudy among participants of a trial of immediate vs delayed treatment of early GDM diagnosed by 2013 World Health Organization criteria, all women treated immediately and those with delayed diagnosis at 24-28 weeks' gestation (treated as if late GDM) were instructed to monitor capillary blood glucose (BG) four times a day (fasting and 2-h postprandial) until delivery. Optimal glycemia was defined as ≥95% of BG measurements between 70 and 140 mg/dL (3.9-7.8 mmol/L).

RESULTS: Overall, 107,716 BG values were obtained from 329 of 549 (59.9%) women (mean age 32.3 ± 4.9 years, BMI 32.0 ± 8.0 kg/m2, 35% European, gestation at GDM diagnosis 15.2 ± 2.4 weeks). Women treated early (n = 213) showed lower mean glucose (MG) and mean fasting glucose (MFG) compared with those treated late (n = 116) (MG: 5.7 ± 0.4 vs. 5.9 ± 0.5, P < 0.001; MFG: 5.2 ± 0.3 vs. 5.3 ± 0.4, P = 0.004), with greater optimal glycemia (74.6% vs. 59.5%, P = 0.006) and similar glycemic variability. MG was similar from 30 weeks' gestation. Overall, optimal glycemia was achieved in 69% of women and associated with lower birth weight, fewer large-for-gestational-age infants (14.4% vs. 26.7%, P = 0.01), more small-for-gestational-age infants (15.3% vs. 5.9%, P = 0.02), and lower gestational weight gain (4.9 ± 6.4 vs. 7.6 ± 6.2 kg, P = 0.001). Suboptimal glycemia was associated with non-European ethnicity, prior GDM, 1-h glucose at booking oral glucose tolerance test, and insulin use.

CONCLUSIONS: Both early and delayed treatment of early GDM resulted in similar glycemia toward the end of pregnancy. Early treatment was associated with improved glycemia overall.

INTRODUCTION: Investigating factors associated with contraceptive satisfaction is important to create a basis for tailored contraceptive counseling. In this study, we aimed to explore how sociodemographic characteristics affected women's level of satisfaction and choice of different contraceptive methods, using data collected during a randomized controlled trial (RCT) in the region Örebro County, Sweden.

METHODS: This cross-sectional study utilized data from a previously conducted RCT. Eligible participants were women aged 20-40 years who sought contraceptive counseling. All women who participated in the RCT and completed a follow-up questionnaire were included in the analysis.

RESULTS: Between February 2015 and March 2016, 1,946, participants were enrolled in the trial, with 1,198 (61.6%) completing the 2-month follow-up questionnaire. Overall, 81.3% of women reported being 'very satisfied' or 'satisfied' with their contraceptive method. Participants aged 27-40 years used long-acting reversible contraception (LARC) to a higher extent compared with those aged 20-26 years (adjusted odds ratio [aOR] 1.92, 95% confidence interval [CI] 1.44-2.56). Older age was associated with lower satisfaction (aOR 0.55, 95% CI 0.33-0.94).Participants with a body mass index (BMI) ≥ 25 more often used LARC (aOR 1.68, 95% CI 1.24-2.28) but were also more likely to report no use of contraceptives at all (aOR 1.56, 95% CI 1.01-2.43) compared with BMI < 25. The level of satisfaction tended to decrease with increasing BMI. Country of birth and educational level were not associated with satisfaction.

CONCLUSIONS: The use of LARC was more common among women with BMI ≥ 25 and older women. While BMI, education, and place of birth did not affect satisfaction, women aged 27-40 reported lower satisfaction. These findings contrast with prior studies and highlight the complex sociodemographic influences on contraception experiences.

OBJECTIVE: To identify factors associated with neonatal respiratory distress (NRD) in early Gestational diabetes mellitus (eGDM).

DESIGN: Nested case-control analysis of the TOBOGM trial.

SETTING: Seventeen hospitals: Australia, Sweden, Austria and India. POPULATION: Pregnant women, <20 weeks' gestation, singleton, GDM risk factors.

METHODS: Women with GDM risk factors completed an oral glucose tolerance test (OGTT) before 20 weeks: those with eGDM (WHO-2013 criteria) were randomised to immediate or deferred GDM treatment. Logistic regression compared pregnancies with/without NRD, and in pregnancies with NRD, those with/without high-dependency nursery admission for ≤24 h with those admitted for >24 h. Comparisons were adjusted for age, pre-pregnancy body mass index, ethnicity, smoking, primigravity, education and site. Adjusted odds ratios (95% CI) are reported.

MAIN OUTCOME MEASURES: NRD definition: ≥4 h of respiratory support (supplemental oxygen or supported ventilation) postpartum. Respiratory distress syndrome (RDS): Supported ventilation and ≥24 h nursery stay.

RESULTS: Ninety-nine (12.5%) of 793 infants had NRD; incidence halved (0.50, 0.31-0.79) if GDM treatment was started early. NRD was associated with Caesarean section (2.31, 1.42-3.76), large for gestational age (LGA) (1.83, 1.09-3.08) and shorter gestation (0.95, 0.93-0.97 per day longer). Among NRD infants, >24 h nursery-stay was associated with higher OGTT 1-h glucose (1.38, 1.08-1.76 per mmol/L). Fifteen (2.0%) infants had RDS.

CONCLUSIONS: Identifying and treating eGDM reduces NRD risk. NRD is more likely with Caesarean section, LGA and shorter gestation. Further studies are needed to understand the mechanisms behind this eGDM complication and any long-term effects.

OBJECTIVE: To compare the prevalence and clinical characteristics of early gestational diabetes (eGDM) and associated birth outcomes amongst women of different ethnic groups.

RESEARCH DESIGN AND METHODS: This is a secondary analysis of an international, multicentre randomized controlled trial of treating eGDM among pregnant women with GDM risk factors enrolled <20 weeks' gestation. The diagnosis of GDM was made using WHO-2013 criteria. While Europids required at least one risk factor for recruitment, for others, ethnicity itself was a risk factor.

RESULTS: Among women of Europid (n=1,567), South Asian (SA: n=971), East and South-East Asian (ESEA: n=498), Middle Eastern (ME: n=242) and Māori and Pasifika (MP: n=174) ethnicities; MP (26.4%) had the highest eGDM crude prevalence compared with Europid (20.3%), SA (24.7%), ESEA (22.3%) and ME (21.1%) (p<0.001). Compared with Europid, the highest eGDM adjusted odds ratio (aOR) was seen in SA (2.43 [95%CI 1.9-3.11]) and ESEA (aOR 2.28 [95%CI 1.68-3.08]); in late GDM, SA had the highest prevalence (20.4%: aOR 2.16 [95%CI 1.61-2.9]). Glucose patterns varied between ethnic groups and ESEA were predominantly diagnosed with eGDM through post-glucose load values, while all other ethnic groups were mainly diagnosed on fasting glucose values. There were no differences in the eGDM composite primary outcome or neonatal and pregnancy-related hypertension outcomes between the ethnic groups.

CONCLUSIONS: In women with risk factors, eGDM was most prevalent in SA and ESEA women, particularly identified by the post-glucose load samples. These findings suggest an early OGTT should particularly be performed in women from these ethnic groups.

OBJECTIVE: To estimate the effect on healthcare resource use after introducing the World Health Organization diagnostic criteria (WHO-2013) for gestational diabetes mellitus (GDM) compared to former criteria in Sweden (SWE-GDM). DESIGN: A cost-analysis alongside the Changing Diagnostic Criteria for Gestational Diabetes (CDC4G) randomised controlled trial.

SETTING: Sweden, with risk-factor based screening for GDM. POPULATION: 47 080 pregnant women and their infants. METHODS: A register-based cost-analysis from a healthcare perspective alongside a stepped-wedge cluster RCT of switching from SWE-GDM to WHO-2013 criteria in 2018. Analyses were made on the population level and repeated in the subgroup affected by the intervention, that is, those with plasma glucose values between SWE-GDM and WHO-2013 criteria. Sensitivity analysis by bootstrapping was performed.

MAIN OUTCOME MEASURES: Estimated costs for obstetric surveillance (including GDM-management), delivery and neonatal healthcare until 28 days postpartum. RESULTS: On a population level, the WHO-2013 criteria were associated with increased costs of obstetric surveillance (adjusted mean [bootstrap confidence interval]) €94.0 [24.5-169.1], delivery care €20.4 [-33.5 to 75.4] and neonatal care €331.0 [75.1-589.0] per pregnancy, and in the affected subgroup €606.9 [377.7-872.4], €348.5 [126.0-542.0] and €129.3 [-559.0 to 980.9] respectively.

CONCLUSIONS: Implementation of the WHO-2013 criteria in Sweden was associated with increased costs for obstetric surveillance and delivery on a population level, driven by the affected subgroup. The increased costs for neonatal care were associated with large uncertainty. A detailed understanding of the changes in resource use can guide decisions to mitigate cost increases.

OBJECTIVE: Despite major medical and public health efforts to reduce excess fetal growth in type 1 diabetes (T1D), large population-based studies assessing the population-level effects are lacking. We assessed temporal trends in the overall distribution of birthweights (BW) and ponderal index (PI) in offspring of T1D mothers, and the impact of maternal BMI.

RESEARCH DESIGN, AND METHODS: Population-based cohort study of all live-born infants to T1D mothers between 1998 and 2016 across Sweden, using data from national registers. Main outcome measures were percentiles of BW and PI. We compared the first 10 years, 1998-2007 (period 1), with the last 10 years, 2008-2016 (period 2), using quantile regression and adjusting for maternal characteristics and hypertensive disease between periods.

RESULTS: Among 6,485 offspring of T1D mothers, the birth weights and PI distributions did not change between the two study periods, neither for the heaviest infants, LGA, nor for the smallest infants, independent of maternal first trimester BMI. The proportion of LGA remained at 61%.

CONCLUSION: There was no improvement over a 20-year period in the distributions of birth weights or PÍs in offspring of T1D mothers in Sweden, unrelated to maternal BMI. Overall, 61% of offspring of T1D mothers were LGA.

BACKGROUND: There is increasing interest in health care systems worldwide for maternal satisfaction with childbirth experience. The World Health Organisation (WHO) launched a recommendation 2018 regarding women's right to equal and fair intrapartum care, where the importance of pharmacological pain relief was highlighted. Our objective with this systematic review was to summarize and assess the current knowledge regarding the impact of obstetric pharmacological pain relief on maternal satisfaction with childbirth.

METHODS: The databases Pub Med, Cochrane, EMBASE and CINAHL were searched for studies in the English language published after 1998 that investigated the effect of pharmacological pain relief on women´s birth experience after vaginal delivery. Studies reporting assessments of subjective satisfaction with childbirth in women planned for vaginal delivery were selected. The results were summarized narratively. For studies where comparable association measures were available, forest plots are presented. Due to heterogeneity of research questions and indirectness of measuring instruments, no meta-analyses were performed.

RESULTS: A total of 15,136 women were included from 18 studies. Two randomized controlled studies, nine cohort studies, six cross-sectional studies and one case control study, all had a moderate or high risk of bias. The studies used inconsistent methods to measure outcomes; therefore, no conclusion could be drawn regarding a possible correlation between pharmacological pain relief and overall birth experience.

CONCLUSIONS: This systematic review could not show a correlation between pharmacological pain relief and women´s experiences of childbirth, mainly due to large heterogeneity between studies. To evaluate pain relief during labour and improve women´s childbirth experiences, high-quality research is warranted.

TRIAL REGISTRATION: The study was registered in PROSPERO (prospective register of systematic reviews) 18 Dec 2018 (ID 116744).

Within the ConcePTION project we set out to design two mother-infant pair studies collecting breast milk and plasma from the mother and plasma from the infant (for metformin and prednisolone) in order to demonstrate the premises and conditions for investigating potential drug transfer in association with breastfeeding. It is essential that the information from lactation studies is trustworthy and fulfils regulatory standards and requirements for the results to be fit for label. In this paper we describe the premises and conditions for mother-infant pair studies and biobanking for research of collected samples as laid down in regulatory requirements. The studies on metformin are still ongoing. At the time of the study (June 2025), 18 participants had been included in the metformin study and 20 in the prednisolone study. Evidence for the use of medicines in association with breastfeeding is urgently needed, both for already approved and used drugs, and for the development of new drugs. Based on our experiences within the IMI-ConcePTION project, we have described the premises for mother-infant pair studies to be adhered to.