Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP))
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|ClinicalTrials.gov Identifier: NCT00969982|
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : February 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Abortion, Induced||Drug: mifepristone+misoprostol Drug: misoprostol+placebo||Not Applicable|
|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|
|Actual Primary Completion Date :||June 2013|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|