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Open Access Study protocol

Midtrimester preterm prelabour rupture of membranes (PPROM): expectant management or amnioinfusion for improving perinatal outcomes (PPROMEXIL – III trial)

Augustinus S P van Teeffelen1*, David P van der Ham2, Christine Willekes1, Salwan Al Nasiry1, Jan G Nijhuis1, Sander van Kuijk4, Ewoud Schuyt35, Twan L M Mulder6, Maureen T M Franssen7, Dick Oepkes8, Fenna A R Jansen8, Mallory D Woiski9, Mireille N Bekker9, Caroline J Bax10, Martina M Porath11, Monique W M de Laat3, Ben W Mol123 and Eva Pajkrt3

Author Affiliations

1 Department of Obstetrics and Gynaecology, GROW – School for Oncology and Developmental Biology, Maastricht University Medical Centre, P. Debijelaan 25, 6229 HX Maastricht, The Netherlands

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

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

4 Department of Epidemiology, Maastricht University Medical Centre, Maastricht, The Netherlands

5 Julius Centre for Health Sciences and Primary Care, University Medical Centre, Utrecht, The Netherlands

6 Department of Neonatology, Maastricht University Medical Centre, Maastricht, The Netherlands

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

8 Department of Obstetrics, Leiden University Medical Centre, Leiden, The Netherlands

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

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

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

12 School of Paediatrics and Reproductive Health, The Robinson Institute, University of Adelaide, Adelaide, Australia

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BMC Pregnancy and Childbirth 2014, 14:128  doi:10.1186/1471-2393-14-128

Published: 4 April 2014

Abstract

Background

Babies born after midtrimester preterm prelabour rupture of membranes (PPROM) are at risk to develop neonatal pulmonary hypoplasia. Perinatal mortality and morbidity after this complication is high. Oligohydramnios in the midtrimester following PPROM is considered to cause a delay in lung development. Repeated transabdominal amnioinfusion with the objective to alleviate oligohydramnios might prevent this complication and might improve neonatal outcome.

Methods/Design

Women with PPROM and persisting oligohydramnios between 16 and 24 weeks gestational age will be asked to participate in a multi-centre randomised controlled trial. Intervention: random allocation to (repeated) abdominal amnioinfusion (intervention) or expectant management (control). The primary outcome is perinatal mortality. Secondary outcomes are lethal pulmonary hypoplasia, non-lethal pulmonary hypoplasia, survival till discharge from NICU, neonatal mortality, chronic lung disease (CLD), number of days ventilatory support, necrotizing enterocolitis (NEC), periventricular leucomalacia (PVL) more than grade I, severe intraventricular hemorrhage (IVH) more than grade II, proven neonatal sepsis, gestational age at delivery, time to delivery, indication for delivery, successful amnioinfusion, placental abruption, cord prolapse, chorioamnionitis, fetal trauma due to puncture. The study will be evaluated according to intention to treat. To show a decrease in perinatal mortality from 70% to 35%, we need to randomise two groups of 28 women (two sided test, β-error 0.2 and α-error 0.05).

Discussion

This study will answer the question if (repeated) abdominal amnioinfusion after midtrimester PPROM with associated oligohydramnios improves perinatal survival and prevents pulmonary hypoplasia and other neonatal morbidities. Moreover, it will assess the risks associated with this procedure.

Trial registration

NTR3492 Dutch Trial Register (http://www.trialregister.nl webcite).

Keywords:
PPROM; Oligohydramnios; Amnioinfusion; Perinatal mortality; Pulmonary hypoplasia