Status:
TERMINATED
Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP)
Lead Sponsor:
Gynuity Health Projects
Collaborating Sponsors:
University of Puerto Rico
Conditions:
Abortion, Induced
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double...
Eligibility Criteria
Inclusion
- Meet legal criteria to obtain abortion
- Present with closed cervical os and no vaginal bleeding
- Live fetus at time of presentation for service
- Have no contraindications to study procedures, according to provider
- Be able to consent to procedure, either by reading consent document or by having consent document read to her
- Be willing to follow study procedures
Exclusion
- Known previous transmural uterine incision
- Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- Any contraindications to vaginal delivery, including placenta previa
- Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00957346
Start Date
February 1 2011
End Date
January 1 2012
Last Update
November 8 2011
Active Locations (1)
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1
University of Puerto Rico, University District Hospital Medical Science Campus
San Juan, Puerto Rico, 00936-5067