Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb

• Status: Completed
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Combined misoprostol and Foley bulb catheter has been shown to be an effective induction method. However, optimal route of administration for misoprostol has not been established.

Therefore, the purpose of this study is to compare the effectiveness and safety of combination buccal miso-foley to combination vaginal miso-foley for third trimester cervical ripening and induction of labor.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Christiana Care Health Services
• Treatments: Misoprostol; Oxytocin

Criteria

Inclusion Criteria:

• ≥18 years of age

• full term (≥37 weeks) gestations determined by routine obstetrical guidelines

• singleton gestation in cephalic presentation

• Both nulliparous and multiparous women

• Intact membranes

• Cervical dilation ≤2cm

Exclusion Criteria:

• Any contraindication to a vaginal delivery or to misoprostol

• fetal demise

• Multifetal gestation

• prior uterine surgery, previous cesarean section

• Tachysystole was defined as at least 6 contractions in 10 minutes for 2 consecutive 10-minute periods

• women with HIV, and women with medical conditions requiring an assisted second stage

• Additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia, growth restriction <10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler studies, and growth restriction <5th percentile with elevated, absent, or reversal of flow in umbilical artery Doppler studies

As described in previous research (Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016;128(6):1357-1364)