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Open Access Highly Accessed Study protocol

Induction of labour versus expectant monitoring in women with pregnancy induced hypertension or mild preeclampsia at term: the HYPITAT trial

Corine M Koopmans12*, Denise Bijlenga3, Jan G Aarnoudse1, Erik van Beek4, Dick J Bekedam5, Paul P van den Berg1, Jan M Burggraaff6, Erwin Birnie3, Kitty WM Bloemenkamp7, Addi P Drogtrop8, Arie Franx9, Christianne JM de Groot10, Anjoke JM Huisjes11, Anneke Kwee12, Saskia le Cessie13, Aren J van Loon2, Ben WJ Mol1415, Joris AM van der Post14, Frans JME Roumen16, Hubertina CJ Scheepers17, Marc EA Spaanderman17, Rob H Stigter18, Christine Willekes19 and Maria G van Pampus1

Author Affiliations

1 Department of Obstetrics and Gynaecology, University Medical Centre Groningen, The Netherlands

2 Department of Obstetrics and Gynaecology, Martini Hospital Groningen, The Netherlands

3 Department of Social Medicine, Academic Medical Centre Amsterdam, The Netherlands

4 Department of Obstetrics and Gynaecology, Sint Antonius Hospital Nieuwegein, The Netherlands

5 Department of Obstetrics and Gynaecology, Onze Lieve Vrouwen Gasthuis Amsterdam, The Netherlands

6 Department of Obstetrics and Gynaecology, Scheper Hospital Emmen, The Netherlands

7 Department of Obstetrics and Gynaecology, Leiden University Medical Centre, The Netherlands

8 Department of Obstetrics and Gynaecology, Twee Steden Hospital Tilburg, The Netherlands

9 Department of Obstetrics and Gynaecology, Sint Elisabeth Hospital Tilburg, The Netherlands

10 Department of Obstetrics and Gynaecology, Medical Centre Haaglanden Den Haag, The Netherlands

11 Department of Obstetrics and Gynaecology, Gelre Hospital Apeldoorn, The Netherlands

12 Department of Perinatology and Gynaecology, University Medical Centre Utrecht, The Netherlands

13 Department of Mediacl Statistics, Leiden University Medical Centre, The Netherlands

14 Department of Obstetrics and Gynaecology, Academic Medical Centre Amsterdam, The Netherlands

15 Department of Obstetrics and Gynaecology, Maxima Medical Centre Veldhoven, The Netherlands

16 Department of Obstetrics and Gynaecology, Atrium Medical Centre Heerlen, The Netherlands

17 Department of Obstetrics and Gynaecology, University Medical Centre Nijmegen, The Netherlands

18 Department of Obstetrics and Gynaecology, Deventer Hospital, The Netherlands

19 Department of Obstetrics and Gynaecology, University Hospital Maastricht, The Netherlands

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BMC Pregnancy and Childbirth 2007, 7:14  doi:10.1186/1471-2393-7-14

Published: 27 July 2007

Abstract

Background

Hypertensive disorders, i.e. pregnancy induced hypertension and preeclampsia, complicate 10 to15% of all pregnancies at term and are a major cause of maternal and perinatal morbidity and mortality. The only causal treatment is delivery. In case of preterm pregnancies conservative management is advocated if the risks for mother and child remain acceptable. In contrast, there is no consensus on how to manage mild hypertensive disease in pregnancies at term. Induction of labour might prevent maternal and neonatal complications at the expense of increased instrumental vaginal delivery rates and caesarean section rates.

Methods/Design

Women with a pregnancy complicated by pregnancy induced hypertension or mild preeclampsia at a gestational age between 36+0 and 41+0 weeks will be asked to participate in a multi-centre randomised controlled trial. Women will be randomised to either induction of labour or expectant management for spontaneous delivery. The primary outcome of this study is severe maternal morbidity, which can be complicated by maternal mortality in rare cases. Secondary outcome measures are neonatal mortality and morbidity, caesarean and vaginal instrumental delivery rates, maternal quality of life and costs. Analysis will be by intention to treat. In total, 720 pregnant women have to be randomised to show a reduction in severe maternal complications of hypertensive disease from 12 to 6%.

Discussion

This trial will provide evidence as to whether or not induction of labour in women with pregnancy induced hypertension or mild preeclampsia (nearly) at term is an effective treatment to prevent severe maternal complications.

Trial Registration

The protocol is registered in the clinical trial register number ISRCTN08132825.