Status:
COMPLETED
Sublingual Versus Vaginal Misoprostol for Labor Induction at Term
Lead Sponsor:
American University of Beirut Medical Center
Conditions:
Induction of Labor
Eligibility:
FEMALE
16-45 years
Phase:
PHASE3
Brief Summary
Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the United States since 1988 as a gastric cytoprotective agent. In contradistinction to prostaglandin E2 prepara...
Detailed Description
Misoprostol, a synthetic prostaglandin E1 analog, has been given both orally and vaginally for induction of labor in the third trimester.1 Vaginal misoprostol has been shown to be more efficacious tha...
Eligibility Criteria
Inclusion
- Live singleton pregnancy at a gestational age of 36 wks or more with a medical or obstetric indication for induction
- Both nulliparous and multiparous women
- A cephalic presentation
- An unfavorable cervix (Bishop's score less than 8)
- A reassuring fetal heart tracing.
Exclusion
- Rupture of membranes
- Multiple gestation
- Malpresentation (presentation other than cephalic)
- Previous cesarean delivery
- Known contraindications to the use of prostaglandins (e.g. asthma)
- Grandmultiparity (more than 5)
- Significant fetal or maternal concerns that made induction necessary under continuous monitoring (e.g. severe IUGR, severe preeclampsia)
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00140114
Start Date
January 1 2004
End Date
September 1 2006
Last Update
July 13 2012
Active Locations (1)
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1
American University of Beirut Medical Center
Beirut, Lebanon