Foley Bulb With Oral Misoprostol for Induction of Labor

Completed · Not applicable

Conditions studied: Pregnancy, Labor, Induced

In brief

Induction of labor is associated with increased cesarean delivery rates, particularly in women with an unfavorable cervix. Both pharmacologic and mechanical methods are utilized for cervical ripening and labor induction. Evidence on the safety and effectiveness of various mechanical and pharmacologic methods of cervical ripening and labor induction is abundant, and yet the majority of clinical trials evaluate time to delivery, rather than mode of delivery. This is a prospective, cluster-randomized clinical trial to compare a standard method of induction at our institution (oral misoprostol) with an alternative, commonly used combination method of oral misoprostol and transcervical foley bulb in women with term pregnancies requiring induction of labor.

Key facts

Study ID

NCT03407625

Run by

University of Texas Southwestern Medical Center

People needed

2227

Starts

2018-01-01

Expected to finish

2019-05-13

Last updated by the study team

2020-11-04

Who can join

Age: 10 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 37 weeks gestation or greater
• Living, singleton fetus
• No major fetal malformations
• Cephalic presentation
• No prior uterine scar
• Intact fetal membranes
• Qualifies for prostaglandin administration according to current Parkland protocol
• Have a cervical dilation of 2 centimeters or less, measured at the level of the internal os
• Have an indication for induction or attempted induction of labor according to Parkland protocol

You may not qualify if…

• latex allergy
• non-reassuring fetal status
• HIV
• active herpes outbreak
• Prior uterine scar
• Contraindication to prostaglandins according to current Parkland protocol
• Contraindication to vaginal delivery

Where it is running

• Parkland Health and Hospital Systems — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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