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Induction of labour at 41 weeks versus expectant management and induction of labour at 42 weeks (SWEdish Post-term Induction Study, SWEPIS): multicentre, open label, randomised, superiority trial
Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Sahlgrenska University Hospital, Gothenburg, Sweden.
Department of Women's and Children's Health, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.
Institute of Health and Care Sciences, Sahlgrenska Academy, Gothenburg University, Sweden.
Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Sahlgrenska University Hospital, Gothenburg, Sweden.
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2019 (Engelska)Ingår i: BMJ. British Medical Journal, E-ISSN 1756-1833, Vol. 367, artikel-id l6131Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

OBJECTIVE: To evaluate if induction of labour at 41 weeks improves perinatal and maternal outcomes in women with a low risk pregnancy compared with expectant management and induction of labour at 42 weeks.

DESIGN: Multicentre, open label, randomised controlled superiority trial.

SETTING: 14 hospitals in Sweden, 2016-18.

PARTICIPANTS: 2760 women with a low risk uncomplicated singleton pregnancy randomised (1:1) by the Swedish Pregnancy Register. 1381 women were assigned to the induction group and 1379 were assigned to the expectant management group.

INTERVENTIONS: Induction of labour at 41 weeks and expectant management and induction of labour at 42 weeks.

MAIN OUTCOME MEASURES: The primary outcome was a composite perinatal outcome including one or more of stillbirth, neonatal mortality, Apgar score less than 7 at five minutes, pH less than 7.00 or metabolic acidosis (pH <7.05 and base deficit >12 mmol/L) in the umbilical artery, hypoxic ischaemic encephalopathy, intracranial haemorrhage, convulsions, meconium aspiration syndrome, mechanical ventilation within 72 hours, or obstetric brachial plexus injury. Primary analysis was by intention to treat.

RESULTS: The study was stopped early owing to a significantly higher rate of perinatal mortality in the expectant management group. The composite primary perinatal outcome did not differ between the groups: 2.4% (33/1381) in the induction group and 2.2% (31/1379) in the expectant management group (relative risk 1.06, 95% confidence interval 0.65 to 1.73; P=0.90). No perinatal deaths occurred in the induction group but six (five stillbirths and one early neonatal death) occurred in the expectant management group (P=0.03). The proportion of caesarean delivery, instrumental vaginal delivery, or any major maternal morbidity did not differ between the groups.

CONCLUSIONS: This study comparing induction of labour at 41 weeks with expectant management and induction at 42 weeks does not show any significant difference in the primary composite adverse perinatal outcome. However, a reduction of the secondary outcome perinatal mortality is observed without increasing adverse maternal outcomes. Although these results should be interpreted cautiously, induction of labour ought to be offered to women no later than at 41 weeks and could be one (of few) interventions that reduces the rate of stillbirths.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN26113652.

Ort, förlag, år, upplaga, sidor
BMJ Publishing Group Ltd, 2019. Vol. 367, artikel-id l6131
Nationell ämneskategori
Reproduktionsmedicin och gynekologi
Identifikatorer
URN: urn:nbn:se:oru:diva-78055DOI: 10.1136/bmj.l6131ISI: 000498841000001PubMedID: 31748223Scopus ID: 2-s2.0-85075603743OAI: oai:DiVA.org:oru-78055DiVA, id: diva2:1372544
Anmärkning

Funding Agencies:

Swedish government  

ALF-agreement  ALFGBG-440301 ALFGBG-718721 ALFGBG-70940 ALFGBG-426401

Health Technology Centre at Sahlgrenska University Hospital  

Foundation of the Health and Medical care committee of the Region of Västra Götaland, Sweden  VGFOUREG387351 VGFOUREG640891 VGFOUREG854081

Hjalmar Svensson Foundation  

Foundation Mary von Sydow  

Born Wijk donation fund  

Uppsala-Örebro regional research council  RFR-556711 RFR-736891

Region Örebro County research committee  OLL-715501

ALF-agreement in Stockholm  ALF-561222 ALF-562222 ALF-563222

Centre for Clinical Research Dalarna-Uppsala University, Sweden  CKFUU-417011

Tillgänglig från: 2019-11-25 Skapad: 2019-11-25 Senast uppdaterad: 2019-12-10Bibliografiskt granskad

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