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Open Access Highly Accessed Study protocol

Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia between 34 and 37 weeks' gestation (HYPITAT-II): a multicentre, open-label randomised controlled trial

Josje Langenveld1*, Kim Broekhuijsen2, Gert-Jan van Baaren3, Maria G van Pampus4, Anton H van Kaam5, Henk Groen6, Martina Porath7, Martijn A Oudijk8, Kitty W Bloemenkamp9, Christianne J de Groot10, Erik van Beek11, Marloes E van Huizen12, Herman P Oosterbaan13, Christine Willekes1, Ella J Wijnen-Duvekot14, Maureen T M Franssen6, Denise A M Perquin15, Jan M J Sporken16, Mallory D Woiski17, Henk A Bremer18, Dimitri N M Papatsonis19, Jozien T J Brons20, Mesruwe Kaplan21, Bas W A Nij Bijvanck22, Ben-Willen J Mol3 and HYPITAT-II study group

Author Affiliations

1 Department of Obstetrics and Gynecology, Maastricht University Medical Centre. GROW - School for Oncology and Developmental Biology, The Netherlands

2 Department of Obstetrics and Gynecology, Martini hospital, Groningen, The Netherlands

3 Department of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam, The Netherlands

4 Department of Obstetrics and Gynecology, Onze Lieve Vrouwe Gasthuis Amsterdam

5 Department of Neonatology, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands

6 Department of Epidemiology, University Medical Centre Groningen, The Netherlands

7 Department of Obstetrics and Gynecology, Maxima Medical Centre, Veldhoven, The Netherlands

8 Department of Obstetrics and Gynecology, University Medical Centre Utrecht, The Netherlands

9 Department of Obstetrics and Gynecology, Leiden University Medical Centre, The Netherlands

10 Department of Obstetrics and Gynecology, VU Medical Centre Amsterdam, The Netherlands

11 Department of Obstetrics and Gynecology, St. Antonius Hospital Nieuwegein, The Netherlands

12 Department of Obstetrics and Gynecology, Haga Hospital Den Haag, The Netherlands

13 Department of Obstetrics and Gynecology, Jeroen Bosch Hospital, s’-Hertogenbosch, The Netherlands

14 Department of Obstetrics and Gynecology, VieCuri Medical Centre, Venlo, The Netherlands

15 Department of Obstetrics and Gynecology, Medical Centre Leeuwarden, Leeuwarden, The Netherlands

16 Department of Obstetrics and Gynecology, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands

17 Department of Obstetrics and Gynecology, Radboud Univeristy Nijmegen, Nijmegen, The Netherlands

18 Department of Obstetrics and Gynecology, Reinier de Graaf Hospital, Delft, The Netherlands

19 Department of Obstetrics and Gynecology, Amphia Hospital Breda, The Netherlands

20 Department of Obstetrics and Gynecology, Medical Spectrum Enschede, The Netherlands

21 Department of Obstetrics and Gynecology, Saxenburgh Group, Hardenberg, The Netherlands

22 Department of Obstetrics and Gynecology, Isala Hospital, Zwolle, The Netherlands

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BMC Pregnancy and Childbirth 2011, 11:50  doi:10.1186/1471-2393-11-50

Published: 7 July 2011

Abstract

Background

Gestational hypertension (GH) and pre-eclampsia (PE) can result in severe complications such as eclampsia, placental abruption, syndrome of Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP) and ultimately even neonatal or maternal death. We recently showed that in women with GH or mild PE at term induction of labour reduces both high risk situations for mothers as well as the caesarean section rate. In view of this knowledge, one can raise the question whether women with severe hypertension, pre-eclampsia or deterioration chronic hypertension between 34 and 37 weeks of gestation should be delivered or monitored expectantly. Induction of labour might prevent maternal complications. However, induction of labour in late pre-term pregnancy might increase neonatal morbidity and mortality compared with delivery at term.

Methods/Design

Pregnant women with severe gestational hypertension, mild pre-eclampsia or deteriorating chronic hypertension at a gestational age between 34+0 and 36+6 weeks will be asked to participate in a multi-centre randomised controlled trial. Women will be randomised to either induction of labour or expectant monitoring. In the expectant monitoring arm, women will be induced only when the maternal or fetal condition detoriates or at 37+0 weeks of gestation. The primary outcome measure is a composite endpoint of maternal mortality, severe maternal complications (eclampsia, HELLP syndrome, pulmonary oedema and thromboembolic disease) and progression to severe pre-eclampsia. Secondary outcomes measures are respiratory distress syndrome (RDS), neonatal morbidity and mortality, caesarean section and vaginal instrumental delivery rates, maternal quality of life and costs. Analysis will be intention to treat. The power calculation is based on an expectant reduction of the maternal composite endpoint from 5% to 1% for an expected increase in neonatal RDS from 1% at 37 weeks to 10% at 34 weeks. This implies that 680 women have to be randomised.

Discussion

This trial will provide insight as to whether in women with hypertensive disorders late pre-term, induction of labour is an effective treatment to prevent severe maternal complications without compromising the neonatal morbidity.

Trial Registration

NTR1792 Clinical trial registration: http://www.trialregister.nl webcite