Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb

Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb for Labor Induction at Term: a Randomized Controlled Trial

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.

This randomized controlled trial of consenting women undergoing induction of labor with combined misoprostol and Foley catheter seeks to efficacy of vaginal versus buccal misoprostol route of administration.

This project will include 216 women presenting at Christiana Care Health System. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter combined with misoprostol. Following admission, women will be randomized into either vaginal or buccal misoprostol.

Women will be randomized with equal probability to the intervention group using block randomization stratified by party.

Patients will receive 25 micrograms of misoprostol along with the insertion of a16F Foley catheter. Misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. The remainder of labor management will be at the discretion of each woman's obstetric provider.

Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review

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)