Open Access Study protocol

Induction of labour versus expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks (the PPROMEXIL-trial)

David P van der Ham1*, Jan G Nijhuis2, Ben Willem J Mol3, Johannes J van Beek1, Brent C Opmeer4, Denise Bijlenga5, Mariette Groenewout6, Birgit Arabin7, Kitty WM Bloemenkamp8, Wim J van Wijngaarden9, Maurice GAJ Wouters10, Paula JM Pernet11, Martina M Porath3, Jan FM Molkenboer12, Jan B Derks13, Michael M Kars14, Hubertina CJ Scheepers15, Martin JN Weinans16, Mallory D Woiski15, Hajo IJ Wildschut17 and Christine Willekes2

Author Affiliations

1 Department of Obstetrics and Gynaecology, VieCuri Medical Centre Venlo, the Netherlands

2 Department of Obstetrics and Gynaecology, University Hospital Maastricht, the Netherlands

3 Department of Obstetrics and Gynaecology, Maxima Medical Centre Veldhoven, the Netherlands

4 Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre Amsterdam, the Netherlands

5 Department of Social Medicine, Academic Medical Centre Amsterdam, the Netherlands

6 Department of Obstetrics and Gynaecology, University Medical Centre Groningen, the Netherlands

7 Department of Obstetrics and Gynaecology Isala Klinieken Zwolle, the Netherlands

8 Department of Obstetrics and Gynaecology, University Medical Centre Leiden, the Netherlands

9 Department of Obstetrics and Gynaecology, Bronovo Hospital the Hague, the Netherlands

10 Department of Obstetrics and Gynaecology, VU Medical Centre Amsterdam, the Netherlands

11 Department of Obstetrics and Gynaecology, Kennemer Gasthuis Haarlem, the Netherlands

12 Department of Obstetrics and Gynaecology, Sint Anna Hospital Geldrop, the Netherlands

13 Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, the Netherlands

14 Department of Obstetrics and Gynaecology, Mesos Medical Centre Utrecht, the Netherlands

15 Department of Obstetrics and Gynaecology, University Medical Centre Sint Radboud Nijmegen, the Netherlands

16 Department of Obstetrics and Gynaecology, Gelderse Vallei Hospital Ede, the Netherlands

17 Department of Obstetrics and Gynaecology, Erasmus Medical Centre Rotterdam, the Netherlands

For all author emails, please log on.

BMC Pregnancy and Childbirth 2007, 7:11  doi:10.1186/1471-2393-7-11

Published: 6 July 2007

Abstract

Background

Preterm prelabour rupture of the membranes (PPROM) is an important clinical problem and a dilemma for the gynaecologist. On the one hand, awaiting spontaneous labour increases the probability of infectious disease for both mother and child, whereas on the other hand induction of labour leads to preterm birth with an increase in neonatal morbidity (e.g., respiratory distress syndrome (RDS)) and a possible rise in the number of instrumental deliveries.

Methods/Design

We aim to determine the effectiveness and cost-effectiveness of immediate delivery after PPROM in near term gestation compared to expectant management. Pregnant women with preterm prelabour rupture of the membranes at a gestational age from 34+0 weeks until 37+0 weeks will be included in a multicentre prospective randomised controlled trial. We will compare early delivery with expectant monitoring.

The primary outcome of this study is neonatal sepsis. Secondary outcome measures are maternal morbidity (chorioamnionitis, puerperal sepsis) and neonatal disease, instrumental delivery rate, maternal quality of life, maternal preferences and costs. We anticipate that a reduction of neonatal infection from 7.5% to 2.5% after induction will outweigh an increase in RDS and additional costs due to admission of the child due to prematurity. Under these assumptions, we aim to randomly allocate 520 women to two groups of 260 women each. Analysis will be by intention to treat. Additionally a cost-effectiveness analysis will be performed to evaluate if the cost related to early delivery will outweigh those of expectant management. Long term outcomes will be evaluated using modelling.

Discussion

This trial will provide evidence as to whether induction of labour after preterm prelabour rupture of membranes is an effective and cost-effective strategy to reduce the risk of neonatal sepsis.

Controlled clinical trial register

ISRCTN29313500