Status:
COMPLETED
Foley Bulb With Oral Misoprostol for Induction of Labor
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Pregnancy
Labor, Induced
Eligibility:
FEMALE
10+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The purpose of this study is to determine whether the use of a transcervical foley catheter, in combination with the standard oral misoprostol regimen will result in a decreased primary cesarean deliv...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2019
Estimated Enrollment :
2227 Patients enrolled
Trial Details
Trial ID
NCT03407625
Start Date
January 1 2018
End Date
May 13 2019
Last Update
November 4 2020
Active Locations (1)
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1
Parkland Health and Hospital Systems
Dallas, Texas, United States, 75235