Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP))
|ClinicalTrials.gov Identifier: NCT00969982|
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : February 20, 2014
|Condition or disease||Intervention/treatment|
|Abortion, Induced||Drug: mifepristone+misoprostol Drug: misoprostol+placebo|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial|
|Study Start Date :||June 2009|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
200 mg mifepristone followed by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).
single dose of 200 mg mifepristone followed 24 hours later by 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.
Active Comparator: misoprostol
Placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion up to a maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).
placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.
- Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. [ Time Frame: 48 hours ]
- Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus. [ Time Frame: 48 hours ]
- Provision of additional interventions to manage excessive blood loss [ Time Frame: from start of treatment until discharge ]
- Any heavy bleeding, uterine rupture, or infection requiring additional treatment [ Time Frame: start of treatment until discharge ]
- Total dose of misoprostol. [ Time Frame: Assessed at time of complete abortion with study drug alone or when total maximum dose given. ]
- Pain experienced by the woman as self-reported. [ Time Frame: Assessed during exit interview. ]
- Women's acceptability of the assigned method [ Time Frame: Assessed at exit interview ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969982
|Moldova, Republic of|
|Municipal Clinical Hospital|
|Chishinau, Moldova, Republic of|
|La Rabta Maternity Hospital|
|Principal Investigator:||Beverly Winikoff||Gynuity Health Projects|