Elective induction of labour and expectant management in late-term pregnancy: A prospective cohort study alongside the INDEX randomised controlled trial

Objective: To assess adverse perinatal outcomes and caesarean section of low-risk women receiving elective induction of labour at 41 weeks or expectant management until 42 weeks according to their preferred and actual management strategy. Design: Multicentre prospective cohort study alongside RCT. S...

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Main Authors: Aafke Bruinsma, Judit KJ Keulen, Joep C Kortekaas, Jeroen van Dillen, Ruben G Duijnhoven, Patrick MM Bossuyt, Anton H van Kaam, Joris AM van der Post, Ben W Mol, Esteriek de Miranda
Format: Article
Language:English
Published: Elsevier 2022-12-01
Series:European Journal of Obstetrics & Gynecology and Reproductive Biology: X
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2590161322000266
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author Aafke Bruinsma
Judit KJ Keulen
Joep C Kortekaas
Jeroen van Dillen
Ruben G Duijnhoven
Patrick MM Bossuyt
Anton H van Kaam
Joris AM van der Post
Ben W Mol
Esteriek de Miranda
author_facet Aafke Bruinsma
Judit KJ Keulen
Joep C Kortekaas
Jeroen van Dillen
Ruben G Duijnhoven
Patrick MM Bossuyt
Anton H van Kaam
Joris AM van der Post
Ben W Mol
Esteriek de Miranda
author_sort Aafke Bruinsma
collection DOAJ
description Objective: To assess adverse perinatal outcomes and caesarean section of low-risk women receiving elective induction of labour at 41 weeks or expectant management until 42 weeks according to their preferred and actual management strategy. Design: Multicentre prospective cohort study alongside RCT. Setting: 90 midwifery practices and 12 hospitals in the Netherlands. Population: 3642 low-risk women with uncomplicated singleton late-term pregnancy. Main outcome measures: Composite adverse outcome (perinatal death, Apgar score 5′ < 7, NICU admission, meconium aspiration syndrome), composite severe adverse perinatal outcome (all above with Apgar score 5′ < 4 instead of < 7) and caesarean section. Results: From 2012–2016, 3642 women out of 6088 eligible women for the INDEX RCT, participated in the cohort study for observational data collection (induction of labour n = 372; expectant management n = 2174; unknown preference/management strategy n = 1096).Adverse perinatal outcome occurred in 1.1 % (4/372) in the induction group versus 1.9 % (42/2174) in the expectant group (adjRR 0.56; 95 %CI: 0.17–1.79), with severe adverse perinatal outcome occurring in 0.3 % (1/372) versus 1.0 % (22/2174), respectively (adjRR 0.39; 95 % CI: 0.05–2.88). There were no stillbirths among all 3642 women; one neonatal death occurred in the unknown preference/management group. Caesarean section rates were 10.5 % (39/372) after induction and 8.9 % (193/2174) after expectant management (adjRR 1.32; 95 % CI: 0.95–1.84).A higher incidence of adverse perinatal outcome was observed in nulliparous compared to multiparous women. Nulliparous 1.8 % (3/170) in the induction group versus 2.6 % (30/1134) in the expectant management group (adjRR 0.58; 95 % CI 0.14–2.41), multiparous 0.5 % (1/201) versus 1.1 % (11/1039) (adjRR 0.54; 95 % CI 0.07–24.19). One maternal death due to amniotic fluid embolism occurred after elective induction at 41 weeks + 6 days. Conclusion: In this cohort study among low-risk women receiving the policy of their preference in late-term pregnancy, a non-significant difference was found between induction of labour at 41 weeks and expectant management until 42 weeks in absolute risks of composite adverse (1.1 % versus 1.9 %) and severe adverse (0.3 % versus 1.0 %) perinatal outcome. The risks in this cohort study were lower than in the trial setting. There were no stillbirths among all 3642 women. Caesarean section rates were comparable.
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spelling doaj.art-7769cc17c6bc4ac98449465dcc2f78e12022-12-22T04:19:49ZengElsevierEuropean Journal of Obstetrics & Gynecology and Reproductive Biology: X2590-16132022-12-0116100165Elective induction of labour and expectant management in late-term pregnancy: A prospective cohort study alongside the INDEX randomised controlled trialAafke Bruinsma0Judit KJ Keulen1Joep C Kortekaas2Jeroen van Dillen3Ruben G Duijnhoven4Patrick MM Bossuyt5Anton H van Kaam6Joris AM van der Post7Ben W Mol8Esteriek de Miranda9Amsterdam UMC, University of Amsterdam, Department of Obstetrics and Gynaecology, Amsterdam Reproduction &amp; Development Research Institute, Meibergdreef 9, Amsterdam, the Netherlands; Rotterdam University of Applied Sciences, School of Midwifery, Rochussenstraat 198, Rotterdam, the Netherlands; Corresponding author at: Amsterdam UMC, University of Amsterdam, Department of Obstetrics and Gynaecology, Amsterdam Reproduction &amp; Development Research Institute, Meibergdreef 9, Amsterdam, the Netherlands.Amsterdam UMC, University of Amsterdam, Department of Obstetrics and Gynaecology, Amsterdam Reproduction &amp; Development Research Institute, Meibergdreef 9, Amsterdam, the Netherlands; Zuyd University, Research Center for Midwifery Science, Faculty Midwifery Education &amp; Studies Maastricht, Universiteitssingel 60, Maastricht, the NetherlandsElkerliek Medical Center, Department of Obstetrics &amp; Gynaecology, Wesselmanlaan 25, Helmond, the NetherlandsRadboud University Medical Center, Department of Obstetrics &amp; Gynaecology, Geert Grooteplein Zuid 10, Nijmegen, the NetherlandsAmsterdam UMC, University of Amsterdam, Department of Obstetrics and Gynaecology, Amsterdam Reproduction &amp; Development Research Institute, Meibergdreef 9, Amsterdam, the NetherlandsAmsterdam UMC, University of Amsterdam, Department of Epidemiology &amp; Data Science, Meibergdreef 9, Amsterdam, the NetherlandsAmsterdam UMC, University of Amsterdam, Emma, Children’s hospital, Department of Neonatology, Meibergdreef 9, Amsterdam, the NetherlandsAmsterdam UMC, University of Amsterdam, Department of Obstetrics and Gynaecology, Amsterdam Reproduction &amp; Development Research Institute, Meibergdreef 9, Amsterdam, the NetherlandsMonash University, Department of Obstetrics and Gynaecology, 246 Clayton Road, Clayton, Victoria, Australia; University of Aberdeen, Aberdeen Centre for Women's Health Research, School of Medicine, Medical Sciences and Nutrition, AB24 3FX Aberdeen, UKAmsterdam UMC, University of Amsterdam, Department of Obstetrics and Gynaecology, Amsterdam Reproduction &amp; Development Research Institute, Meibergdreef 9, Amsterdam, the NetherlandsObjective: To assess adverse perinatal outcomes and caesarean section of low-risk women receiving elective induction of labour at 41 weeks or expectant management until 42 weeks according to their preferred and actual management strategy. Design: Multicentre prospective cohort study alongside RCT. Setting: 90 midwifery practices and 12 hospitals in the Netherlands. Population: 3642 low-risk women with uncomplicated singleton late-term pregnancy. Main outcome measures: Composite adverse outcome (perinatal death, Apgar score 5′ < 7, NICU admission, meconium aspiration syndrome), composite severe adverse perinatal outcome (all above with Apgar score 5′ < 4 instead of < 7) and caesarean section. Results: From 2012–2016, 3642 women out of 6088 eligible women for the INDEX RCT, participated in the cohort study for observational data collection (induction of labour n = 372; expectant management n = 2174; unknown preference/management strategy n = 1096).Adverse perinatal outcome occurred in 1.1 % (4/372) in the induction group versus 1.9 % (42/2174) in the expectant group (adjRR 0.56; 95 %CI: 0.17–1.79), with severe adverse perinatal outcome occurring in 0.3 % (1/372) versus 1.0 % (22/2174), respectively (adjRR 0.39; 95 % CI: 0.05–2.88). There were no stillbirths among all 3642 women; one neonatal death occurred in the unknown preference/management group. Caesarean section rates were 10.5 % (39/372) after induction and 8.9 % (193/2174) after expectant management (adjRR 1.32; 95 % CI: 0.95–1.84).A higher incidence of adverse perinatal outcome was observed in nulliparous compared to multiparous women. Nulliparous 1.8 % (3/170) in the induction group versus 2.6 % (30/1134) in the expectant management group (adjRR 0.58; 95 % CI 0.14–2.41), multiparous 0.5 % (1/201) versus 1.1 % (11/1039) (adjRR 0.54; 95 % CI 0.07–24.19). One maternal death due to amniotic fluid embolism occurred after elective induction at 41 weeks + 6 days. Conclusion: In this cohort study among low-risk women receiving the policy of their preference in late-term pregnancy, a non-significant difference was found between induction of labour at 41 weeks and expectant management until 42 weeks in absolute risks of composite adverse (1.1 % versus 1.9 %) and severe adverse (0.3 % versus 1.0 %) perinatal outcome. The risks in this cohort study were lower than in the trial setting. There were no stillbirths among all 3642 women. Caesarean section rates were comparable.http://www.sciencedirect.com/science/article/pii/S2590161322000266Late-term pregnancyInduction of laborExpectant managementPerinatal outcomeMaternal outcomeCesarean section
spellingShingle Aafke Bruinsma
Judit KJ Keulen
Joep C Kortekaas
Jeroen van Dillen
Ruben G Duijnhoven
Patrick MM Bossuyt
Anton H van Kaam
Joris AM van der Post
Ben W Mol
Esteriek de Miranda
Elective induction of labour and expectant management in late-term pregnancy: A prospective cohort study alongside the INDEX randomised controlled trial
European Journal of Obstetrics & Gynecology and Reproductive Biology: X
Late-term pregnancy
Induction of labor
Expectant management
Perinatal outcome
Maternal outcome
Cesarean section
title Elective induction of labour and expectant management in late-term pregnancy: A prospective cohort study alongside the INDEX randomised controlled trial
title_full Elective induction of labour and expectant management in late-term pregnancy: A prospective cohort study alongside the INDEX randomised controlled trial
title_fullStr Elective induction of labour and expectant management in late-term pregnancy: A prospective cohort study alongside the INDEX randomised controlled trial
title_full_unstemmed Elective induction of labour and expectant management in late-term pregnancy: A prospective cohort study alongside the INDEX randomised controlled trial
title_short Elective induction of labour and expectant management in late-term pregnancy: A prospective cohort study alongside the INDEX randomised controlled trial
title_sort elective induction of labour and expectant management in late term pregnancy a prospective cohort study alongside the index randomised controlled trial
topic Late-term pregnancy
Induction of labor
Expectant management
Perinatal outcome
Maternal outcome
Cesarean section
url http://www.sciencedirect.com/science/article/pii/S2590161322000266
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