TY - JOUR
T1 - Midtrimester preterm prelabour rupture of membranes (PPROM)
T2 - Expectant management or amnioinfusion for improving perinatal outcomes (PPROMEXIL - III trial)
AU - van Teeffelen, Augustinus S.P.
AU - van der Ham, David P.
AU - Willekes, Christine
AU - Al Nasiry, Salwan
AU - Nijhuis, Jan G.
AU - van Kuijk, Sander
AU - Schuyt, Ewoud
AU - Mulder, Twan L.M.
AU - Franssen, Maureen T.M.
AU - Oepkes, Dick
AU - Jansen, Fenna A.R.
AU - Woiski, Mallory D.
AU - Bekker, Mireille N.
AU - Bax, Caroline J.
AU - Porath, Martina M.
AU - de Laat, Monique W.M.
AU - Mol, Ben W.
AU - Pajkrt, Eva
PY - 2014/4/4
Y1 - 2014/4/4
N2 - 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).
AB - 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).
KW - Amnioinfusion
KW - Oligohydramnios
KW - Perinatal mortality
KW - PPROM
KW - Pulmonary hypoplasia
UR - http://www.scopus.com/inward/record.url?scp=84899494344&partnerID=8YFLogxK
U2 - 10.1186/1471-2393-14-128
DO - 10.1186/1471-2393-14-128
M3 - Article
C2 - 24708702
AN - SCOPUS:84899494344
SN - 1471-2393
VL - 14
JO - BMC Pregnancy and Childbirth
JF - BMC Pregnancy and Childbirth
IS - 1
M1 - 128
ER -