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The primary goal is to examine the efficacy and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Uzbekistan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women of 13-22 weeks gestation | Pregnant women of 13-22 weeks gestation will receive 200 mg mifepristone followed 24-48 hours later by 400 mcg sublingual misoprostol every three hours until complete expulsion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of abortions that are complete as a measure of efficacy | It is a proportion that specifies how many abortions out of all initiated abortions are complete without recourse to surgical intervention within 15 hours after the start of misoprostol administration. | At 15 hours after the start of misoprostol administration |
| Measure | Description | Time Frame |
|---|---|---|
| Interval of time between induction with misoprostol to complete abortion | It is the length of time between the administration of the first dose of misoprostol and complete abortion. | Every 3 hours from the start of misoprostol administration until complete abortion |
| Women's satisfaction with the method |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Dilfuza Kurbanbekova, PhD, MD | Women's Wellness Center, Uzbekistan | Principal Investigator |
| Tamar Tsereteli, PhD, MD | Gynuity Health Projects | Principal Investigator |
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bukhara Maternity House No. 1 | Bukhara | Uzbekistan | ||||
| Samarkand Perinatal Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31164394 | Derived | Platais I, Tsereteli T, Maystruk G, Kurbanbekova D, Winikoff B. A prospective study of mifepristone and unlimited dosing of sublingual misoprostol for termination of second-trimester pregnancy in Uzbekistan and Ukraine. BMJ Sex Reprod Health. 2019 Jun 4:bmjsrh-2018-200167. doi: 10.1136/bmjsrh-2018-200167. Online ahead of print. |
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It is a scale that assesses the level of a woman's satisfaction with the procedure. |
| At discharge, up to 5 days after enrollment |
| Side effects experienced by women | It is a brief questionnaire that records all side effects experienced by women. | Every 3 hours from the start of misoprostol administration until complete abortion |
| Pain experienced by women | It is a scale that assesses the acceptability of pain experienced by the woman. | At the time of discharge, up to 5 days after enrollment |
| Complications during induction and after discharge | It is a record of complications and their treatment during induction and up to 1 month after discharge. | Every 3 hours from the start of misoprostol administration, up to 1 month after discharge |
| Women's perception of acceptability of the procedure | It is a scale that assesses the acceptability of the procedure for the woman. | At discharge, up to 5 days after enrollment |
| Provider's perception of acceptability of the method | It is a questionnaire that assesses the acceptability of the method for the provider. | At study completion, up to 2 years after study enrollment commences |
| Total dose of misoprostol administered | Count of the total dose of misoprostol administered from the first dose to complete abortion. | Every 3 hours from start of misoprostol administration to complete abortion |
| Samarkand |
| Uzbekistan |
| Clinic No. 2, Tashkent Medical Academy | Tashkent | Uzbekistan |