Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial

• Status: Completed
• Trial end date: 2018-06-24
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Misoprostol

Criteria

Inclusion Criteria

• Nulliparous women aged 18 or above

• BMI ≥ 30 at the time of labor induction

• Singleton gestation

• Cephalic presentation (includes successful external cephalic version)

• Intact fetal membranes

• Unfavorable cervix (Bishop score of ≤ 6)

• Gestational age ≥ 32 weeks

Exclusion Criteria

• Patient not candidate for IOL with misoprostol as deemed by the treating physician

• Multiple gestation

• Major fetal anomalies

• Fetal demise