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

BMC Pregnancy and Childbirth

Eva Pajkrt⁹  Ben W Mol⁹  Monique W M de Laat⁹  Martina M Porath^1,10  Caroline J Bax³  Mireille N Bekker²  Mallory D Woiski²  Fenna A R Jansen⁷  Dick Oepkes⁷  Maureen T M Franssen⁸  Twan L M Mulder⁴  Ewoud Schuyt⁶  Sander van Kuijk⁵  Jan G Nijhuis^1,11  Salwan Al Nasiry^1,11  Christine Willekes^1,11  David P van der Ham¹  Augustinus S P van Teeffelen^1,11 

[1] Department of Obstetrics and Gynaecology, Martini hospital, Groningen, The Netherlands;Department of Obstetrics and Gynaecology, University Medical Centre Nijmegen, Nijmegen, The Netherlands;Department of Obstetrics and Gynaecology, VU University Medical Centre, Amsterdam, The Netherlands;Department of Neonatology, Maastricht University Medical Centre, Maastricht, The Netherlands;Department of Epidemiology, Maastricht University Medical Centre, Maastricht, The Netherlands;Julius Centre for Health Sciences and Primary Care, University Medical Centre, Utrecht, The Netherlands;Department of Obstetrics, Leiden University Medical Centre, Leiden, The Netherlands;Department of Obstetrics and Gynaecology, University Medical Centre Groningen, Groningen, The Netherlands;Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, The Netherlands;Department of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, The Netherlands;Department of Obstetrics and Gynaecology, GROW – School for Oncology and Developmental Biology, Maastricht University Medical Centre, P. Debijelaan 25, 6229 HX Maastricht, The Netherlands

关键词: Pulmonary hypoplasia;    Perinatal mortality;    Amnioinfusion;    Oligohydramnios;    PPROM;   

Others  :  1127431
DOI  :  10.1186/1471-2393-14-128

 received in 2013-08-19, accepted in 2014-03-26,  发布年份 2014

【 摘 要 】

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).

【 授权许可】

   
2014 van Teeffelen et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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