Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction

NATerminatedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

June 8, 2017

Study Completion Date

June 8, 2017

Conditions
Pregnancy
Interventions
DEVICE

Foley catheter

The Foley catheter is a device used to achieve cervical ripening at the start of labor induction. It is a single balloon catheter placed transcervically by a provider, either digitally or using a speculum for visualization. The balloon is placed above the internal os but below the fetal head, amniotic membranes, and placenta and is inflated. In this study, it will be inflated with 60 cc of normal saline and taped to the patient's thigh for traction. Over several hours, the balloon gradually dilates the cervix. The catheter is typically expulsed when the cervix is 3-4 centimeters.

DRUG

Misoprostol

Misoprostol is a prostaglandin E1 analogue that is used for cervical ripening during labor induction. A 25 microgram tablet is placed in the vagina by a provider. A new 25 mcg tablet can be used vaginally every 4 hours for up to 6 total doses.

Trial Locations (1)

55905

Mayo Clinic in Rochester, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER