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


METHODS
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).


CONCLUSIONS
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.


BACKGROUND
NTR3492 Dutch Trial Register (http://www.trialregister.nl).
Department of Obstetrics and Gynaecology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, P, Debijelaan 25, 6229 HX Maastricht, The Netherlands. stijn.van.teeffelen@mumc.nl.
Augustinus S P
AS
van Teeffelen
David P
DP
van der Ham
Christine
C
Willekes
Salwan
S
Al Nasiry
Jan G
JG
Nijhuis
Sander
S
van Kuijk
Ewoud
E
Schuyt
Twan L M
TL
Mulder
Maureen T M
MT
Franssen
Dick
D
Oepkes
Fenna A R
FA
Jansen
Mallory D
MD
Woiski
Mireille N
MN
Bekker
Caroline J
CJ
Bax
Martina M
MM
Porath
Monique W M
MW
de Laat
Ben W
BW
Mol
Eva
E
Pajkrt
D000328:Adult; D036861:Delivery, Obstetric / Q000379:methods*; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000453:epidemiology / Q000517:prevention & control*; D005500:Follow-Up Studies; D005865:Gestational Age; D006801:Humans; D007226:Infant Mortality / Q000639:trends; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000453:epidemiology / Q000517:prevention & control*; D009426:Netherlands / Q000453:epidemiology; D018743:Perinatal Care / Q000379:methods*; D054238:Perinatal Mortality / Q000639:trends; D011247:Pregnancy; D011256:Pregnancy Outcome; D011262:Pregnancy Trimester, Second; D012189:Retrospective Studies