TY - JOUR
T1 - Management of late-preterm premature rupture of membranes
T2 - The PPROMEXIL-2 trial
AU - Van Der Ham, David P.
AU - Van Der Heyden, Jantien L.
AU - Opmeer, Brent C.
AU - Mulder, Antonius L.M.
AU - Moonen, Rob M.J.
AU - Van Beek, J. J.
AU - Franssen, Maureen T.M.
AU - Bloemenkamp, Kitty W.M.
AU - Sikkema, J. M.
AU - De Groot, Christianne J.M.
AU - Porath, Martina
AU - Kwee, Anneke
AU - Woiski, Mallory D.
AU - Duvekot, J. J.
AU - Akerboom, Bettina M.C.
AU - Van Loon, Aren J.
AU - De Leeuw, Jan W.
AU - Willekes, Christine
AU - Mol, Ben W.J.
AU - Nijhuis, Jan G.
PY - 2012/10
Y1 - 2012/10
N2 - 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. Study Design: 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. Conclusion: The risk of neonatal sepsis after PPROM near term is low. Induction of labor does not reduce this risk.
AB - 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. Study Design: 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. Conclusion: The risk of neonatal sepsis after PPROM near term is low. Induction of labor does not reduce this risk.
KW - induction of labor
KW - neonatal sepsis
KW - PPROM Expectant Management versus Induction of Labor trial
KW - preterm prelabor rupture of membranes
UR - http://www.scopus.com/inward/record.url?scp=84866924036&partnerID=8YFLogxK
U2 - 10.1016/j.ajog.2012.07.024
DO - 10.1016/j.ajog.2012.07.024
M3 - Article
C2 - 22901981
AN - SCOPUS:84866924036
SN - 0002-9378
VL - 207
SP - 276.e1-276.e10
JO - American Journal of Obstetrics and Gynecology
JF - American Journal of Obstetrics and Gynecology
IS - 4
ER -