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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-blinded trial of 120 women in each country comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mifepristone+misoprostol | Experimental | 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). |
|
| misoprostol | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mifepristone+misoprostol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. | 48 hours | |
| Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Provision of additional interventions to manage excessive blood loss | from start of treatment until discharge | |
| Any heavy bleeding, uterine rupture, or infection requiring additional treatment | start of treatment until discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Municipal Clinical Hospital | Chishinau | Moldova | ||||
| La Rabta Maternity Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25896965 | Derived | Dabash R, Chelli H, Hajri S, Shochet T, Raghavan S, Winikoff B. A double-blind randomized controlled trial of mifepristone or placebo before buccal misoprostol for abortion at 14-21 weeks of pregnancy. Int J Gynaecol Obstet. 2015 Jul;130(1):40-4. doi: 10.1016/j.ijgo.2015.02.023. Epub 2015 Apr 11. |
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| misoprostol+placebo | Drug | 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. |
|
| Total dose of misoprostol. | Assessed at time of complete abortion with study drug alone or when total maximum dose given. |
| Pain experienced by the woman as self-reported. | Assessed during exit interview. |
| Women's acceptability of the assigned method | Assessed at exit interview |
| Tunis |
| Tunisia |