Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

June 4, 2019

Primary Completion Date

January 20, 2020

Study Completion Date

February 1, 2021

Conditions
Induction of Labor
Interventions
DRUG

Misoprostol

"Women randomized to either vaginal or buccal misoprostol-cervical Foley group will have both misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of vaginal or buccal misoprostol along with the insertion of a16F Foley catheter with stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water.~vaginal or Buccal 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. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated."

Trial Locations (1)

19713

Christiana Care Health Systems, Newark

All Listed Sponsors
lead

Christiana Care Health Services

OTHER

NCT03976037 - Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb | Biotech Hunter | Biotech Hunter