A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor

NACompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions
Pregnancy
Interventions
DEVICE

misoprostol

25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist).

DEVICE

Foley bulb

a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient's inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours.

Trial Locations (1)

10019

Mount Sinai Roosevelt, New York

All Listed Sponsors
lead

St. Luke's-Roosevelt Hospital Center

OTHER

NCT02566005 - A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor | Biotech Hunter | Biotech Hunter