Status:
COMPLETED
Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP))
Lead Sponsor:
Gynuity Health Projects
Conditions:
Abortion, Induced
Eligibility:
FEMALE
Phase:
NA
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
- 14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound)
- 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 :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT00969982
Start Date
June 1 2009
End Date
June 1 2013
Last Update
February 20 2014
Active Locations (2)
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1
Municipal Clinical Hospital
Chishinau, Moldova
2
La Rabta Maternity Hospital
Tunis, Tunisia