Status:
COMPLETED
Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon
Lead Sponsor:
Aultman Health Foundation
Conditions:
Induction of Labor
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon...
Detailed Description
The design of this study is a randomized, controlled study with two arms. Both groups will undergo placement of a Foley catheter, through the external and internal os of the cervix, according to stand...
Eligibility Criteria
Inclusion
- Participant or surrogate is capable of giving informed consent
- Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy
- Participant is undergoing an indicated induction of labor
- Participant is found to have cervical Bishop score ≤5 on initial cervical exam
- Participant has no medical or obstetrical contraindications to induction of labor
Exclusion
- Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods
- Manufacturer's contraindications to misoprostol or oxytocin
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01139801
Start Date
September 1 2009
End Date
March 1 2010
Last Update
August 24 2018
Active Locations (1)
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1
Aultman Health Foundation
Canton, Ohio, United States, 44710