Status:
COMPLETED
Labor Induction With Oral Versus Vaginal Misoprostol
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Pregnancy
Labor, Induced
Eligibility:
FEMALE
10+ years
Brief Summary
This study will compare vaginal and oral misoprostol, to determine whether a vaginal misoprostol regimen achieves a higher vaginal delivery rate in a real-world, high-volume setting, and whether this ...
Detailed Description
The purpose of this study is to determine whether the use of a standardized vaginal misoprostol regimen will result in a decreased primary cesarean delivery rate among women with a cervical dilation o...
Eligibility Criteria
Inclusion
- Nulliparous and multiparous pregnant women
- 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
- Non-reassuring fetal status
- Active herpes outbreak
- Prior uterine scar
- Contraindication to prostaglandins according to current Parkland protocol (including 4 or more painful contractions per 10 min prior to prostaglandin administration)
- Contraindication to vaginal delivery
Key Trial Info
Start Date :
May 24 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 7 2023
Estimated Enrollment :
2546 Patients enrolled
Trial Details
Trial ID
NCT04755218
Start Date
May 24 2021
End Date
July 7 2023
Last Update
April 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Parkland Health and Hospital Systems
Dallas, Texas, United States, 75235