Phase 4
N=236
Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial
Obesity · Labor Induction · Cesarean Delivery
Bottom Line
View on ClinicalTrials.gov: NCT02639429 ↗Enrolled (actual)
236
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Number of Participants With a Need for Cesarean Delivery — 51; 53 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vaginal Misoprostol (Drug); Foley Balloon + Vaginal Misoprostol (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Need for Cesarean Delivery |
51; 53 | — |
| SECONDARY Indication for Cesarean Delivery |
31; 28; 13; 18; 7; 7 | — |
| SECONDARY Induction-to-delivery Interval in Hours |
24.8; 24.5 | — |
| SECONDARY Number of Participants With a Need for Oxytocin Augmentation |
89; 103 | — |
| SECONDARY Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities |
10; 20 | — |
| SECONDARY Number of Participants With Clinical Chorioamnionitis |
1; 1 | — |
| SECONDARY Number of Participants With a Need for Operative Vaginal Delivery |
5; 6 | — |
| SECONDARY Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity |
0; 3; 3; 0; 5; 1 | — |
| SECONDARY Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU) |
24; 20 | — |
| SECONDARY Number of Newborns With Transient Tachypnea (TTN) |
5; 5 | — |
| SECONDARY Number of Newborns With Respiratory Distress Syndrome (RDS) |
5; 4 | — |
| SECONDARY Number of Newborns With Meconium Aspiration Syndrome |
— | — |
| SECONDARY Number of Newborns With Culture-proven Sepsis |
0; 1 | — |
| SECONDARY Number of Newborns With Seizures |
0; 0 | — |
| SECONDARY Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity |
4; 3; 5; 5; 3; 3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02639429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.