Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial
Status:
Completed
Trial end date:
2018-06-24
Target enrollment:
Participant gender:
Summary
Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts
to require induction of labor because of increased rates of obstetric complications including
pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies
have shown that obese women experience increased labor duration and oxytocin needs when
compared to normal-weight women. This in turn results in increased rates for unplanned
cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and
non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of
obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix
(Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol
will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.
Phase:
Phase 4
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston