Cervical Ripening in Premature Rupture of Membranes
Status:
Completed
Trial end date:
2016-05-30
Target enrollment:
Participant gender:
Summary
Premature rupture of membranes (PROM) is diagnosed by demonstrating amniotic fluid in the
vaginal canal before the onset of labor. The integrity of the amniotic membrane is
compromised thereby increasing the risk of intrauterine infection and compression of the
umbilical cord. PROM complicates 3% to 8% of pregnancies in the US and is responsible for 30%
of preterm births. Intrauterine infection remains the most significant maternal and neonatal
sequelae associated with PROM and this risk increases with the length of time from ruptured
membrane to delivery. Induction of labor has been shown to reduce the rates of
chorioamnionitis, endometritis and NICU admissions4. Specifically, induction of labor with
prostaglandin agents followed by oxytocin, versus oxytocin alone has been shown to be
effective for labor induction resulting in vaginal delivery. Management strategies for PROM
have been controversial, and published studies on outcomes are over one to two decades old,
which does not account for changes in clinical trends and practice patterns. Recently ACOG
recommends that patients presenting at 37 weeks gestation or greater with PROM should be
induced if not in labor, and "generally with oxytocin". In women with PROM without the onset
of labor, the cervix is commonly unfavorable and induction with oxytocin alone may lead to an
increased risk of cesarean section. With a c-section rate as high as 33%, women undergoing
induction of labor have an increased risk of c-section and its associated morbidity and long
term sequela. ACOG's recommendation for the use of oxytocin as the induction agent may be
meant to avoid a theoretical increased risk of chorioamnionitis in this patient population
however it does not take into account the status of the cervix, which may result in a
increased risk of c-section. The purpose of the proposed study is to determine whether
cervical ripening in women with PROM and an unfavorable cervix is associated with increase
rates of vaginal delivery and decreased cesarean section rate compared to induction of labor
with oxytocin alone. The investigators aim to determine the incidence of endometritis, and
neonatal infection associated with PROM in the current medical environment of antibiotic
prophylaxis and antenatal steroid use, taking into account the changes in patient
characteristics.