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| Name | Class |
|---|---|
| University of Puerto Rico | OTHER |
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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 20 women 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 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses. |
|
| Misoprostol | Placebo Comparator | Placebo resembling 200mcg mifepristone followed by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone+misoprostol | Drug | single dose of 200 mg mifepristone followed 24 hours later by 400 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention. | every 3 hours | |
| Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus; approximately 10-24 hours. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Provision of additional interventions to manage excessive blood loss. | Within 30 days of mifepristone administration. | |
| Total dose of misoprostol. | Assessed at time of complete abortion with study drug alone or when total maximum dose given: approximately 10-24 hours after first dose of misoprostol administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winkoff, M.D., M.P.H | Gynuity Health Projects | Principal Investigator |
| Yari Vale-Moreno, M.D. | University of Puerto Rico Department of Obstetrics and Gynecology | Principal Investigator |
| Melanie Pena, MPH, MA | Gynuity Health Projects | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Puerto Rico, University District Hospital Medical Science Campus | San Juan | 00936-5067 | Puerto Rico |
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| Placebo+Misoprostol | Drug | placebo resembling mifepristone followed 24 hours later by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses. |
|
| Any heavy bleeding, uterine rupture, or infection requiring additional treatment | Within 30 days of mifepristone administration. |
| Pain experienced by the woman | Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration. |
| Women's acceptability of the assigned method | Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration. |