Status:
TERMINATED
Buccal Versus Vaginal Misoprostol for Third Trimester Induction of Labor
Lead Sponsor:
University of California, Los Angeles
Conditions:
Pregnancy
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief Summary
Approximately 22% of term pregnancies are induced. Misoprostol, a prostaglandin E1 analogue, is a widely accepted induction agent, that has been proven safe and effective for induction of labor. It st...
Detailed Description
Design Overview This will be a prospective, double blind, randomized, placebo-controlled trial comparing buccal versus vaginal misoprostol in equal doses (25 mcg every 4 hours). Each participant will ...
Eligibility Criteria
Inclusion
- Willingness to participate / consent in a placebo-controlled trial
- Age 18 and older
- Pregnancy between 34 and 42 years of gestation
- Admitted for labor induction because of either medical, obstetric, or psychosocial indications
- Live singleton fetus
- Bishop score less than or equal to six
- Cephalic presentation
- Reactive non-stress test or Negative contraction test
Exclusion
- Premature rupture of membranes
- Multiparity \> 5
- Contraindication to vaginal or labor delivery
- Suspected placental abruption
- Significant hepatic, renal or cardiac disease
- Known hypersensitivity to misoprostol or prostaglandin analogue
- Recent prostaglandin administration for induction of labor
- Multifetal pregnancy
- Macrosomia \> 4500g estimated fetal weight by ultrasound or leopold
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01519765
Start Date
July 1 2011
End Date
December 1 2014
Last Update
September 27 2016
Active Locations (1)
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1
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095