Outpatient Transcervical Balloon For Induction of Labor

NAUnknownINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

June 9, 2022

Primary Completion Date

June 9, 2023

Study Completion Date

October 1, 2023

Conditions
Induced Vaginal DeliveryInduced; Birth
Interventions
PROCEDURE

Outpatient transcervical foley balloon

These participants will receive a 16-French Foley catheter which will be placed by a physician present in the clinic. The balloon will be inflated with 40 mL of sterile water, and the catheter will then be gently withdrawn so that the balloon applies pressure against the internal os. The catheter will then be taped to the inner thigh.

PROCEDURE

Inpatient Vaginal Misoprostol

These participants will receive 25 micrograms of Misoprostol (100- microgram tablet cut into fourths by the hospital pharmacist) inserted vaginally into the posterior fornix every 4 hours and repeated up to a maximum of six doses per our standard hospital protocol.

Trial Locations (1)

48503

RECRUITING

Hurley Medical Center, Flint

Sponsors
All Listed Sponsors
lead

Hurley Medical Center

OTHER

NCT05798728 - Outpatient Transcervical Balloon For Induction of Labor | Biotech Hunter | Biotech Hunter