Management of late-preterm premature rupture of membranes: the PPROMEXIL-2 trial.
OBJECTIVE
The evidence for the management of near term prelabor rupture of membranes is poor. From January 2007 until September 2009, we performed the PPROM Expectant Management versus Induction of Labor (PPROMEXIL) trial. In this trial, we showed that in women with preterm prelabor rupture of membranes (PPROM), the incidence of neonatal sepsis was low, and the induction of labor (IoL) did not reduce this risk. Because the PPROMEXIL trial was underpowered and because of a lower-than-expected incidence of neonatal sepsis, we performed a second trial (PPROMEXIL-2), aiming to randomize 200 patients to improve the evidence in near-term PPROM.


METHODS
In a nationwide multicenter study, nonlaboring women with PPROM between 34 and 37 weeks' gestational age were eligible for inclusion. Patients were randomized to IoL or expectant management (EM). The primary outcome measure was neonatal sepsis.


RESULTS
From December 2009 until January 2011, we randomized 100 women to IoL and 95 to EM. Neonatal sepsis was seen in 3 neonates (3.0%) in the IoL-group versus 4 neonates (4.1%) in the EM group (relative risk, 0.74; 95% confidence interval, 0.17-3.2). One of the sepsis cases in the IoL group resulted in neonatal death because of asphyxia. There were no significant differences in secondary outcomes.


CONCLUSIONS
The risk of neonatal sepsis after PPROM near term is low. Induction of labor does not reduce this risk.
Department of Obstetrics and Gynecology, Maastricht University Medical Center, GROW-School for Oncology and Developmental Biology, Maastricht, The Netherlands. dpvanderham@gmail.com
David P
DP
van der Ham
Jantien L
JL
van der Heyden
Brent C
BC
Opmeer
Antonius L M
AL
Mulder
Rob M J
RM
Moonen
J Hans J
JH
van Beek
Maureen T M
MT
Franssen
Kitty W M
KW
Bloemenkamp
J Marko M
JM
Sikkema
Christianne J M
CJ
de Groot
Martina
M
Porath
Anneke
A
Kwee
Mallory D
MD
Woiski
J Hans J
JH
Duvekot
Bettina M C
BM
Akerboom
Aren J
AJ
van Loon
Jan W
JW
de Leeuw
Christine
C
Willekes
Ben W J
BW
Mol
Jan G
JG
Nijhuis
D000328:Adult; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000453:epidemiology / Q000628:therapy*; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D007751:Labor, Induced; D008297:Male; D011247:Pregnancy; D011263:Pregnancy Trimester, Third; D018805:Sepsis / Q000175:diagnosis* / Q000453:epidemiology / Q000517:prevention & control; D016896:Treatment Outcome; D057832:Watchful Waiting