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

van Teeffelen, Augustinus S.P.; van der Ham, David; Willekes, Christine; Mulder, Twan L.M.; et al.

doi:10.1186/1471-2393-14-128

Title

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

Author

van Teeffelen, Augustinus S.P.

van der Ham, David

Willekes, Christine

Mulder, Twan L.M.

et al.

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.

Language

English

Source (journal)

BMC pregnancy and childbirth. - London

Publication

London : 2014

ISSN

1471-2393

DOI

10.1186/1471-2393-14-128

Volume/pages

14 (2014) , 7 p.