Mifepristone and Misoprostol for Midtrimester Termination of Pregnancy in Uzbekistan
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|ClinicalTrials.gov Identifier: NCT02235155|
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : January 14, 2016
|Condition or disease|
|Abortion in Second Trimester|
|Study Type :||Observational|
|Actual Enrollment :||135 participants|
|Official Title:||Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Uzbekistan|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
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.
- Proportion of abortions that are complete as a measure of efficacy [ Time Frame: At 15 hours after the start of misoprostol administration ]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.
- Interval of time between induction with misoprostol to complete abortion [ Time Frame: Every 3 hours from the start of misoprostol administration until complete abortion ]It is the length of time between the administration of the first dose of misoprostol and complete abortion.
- Women's satisfaction with the method [ Time Frame: At discharge, up to 5 days after enrollment ]It is a scale that assesses the level of a woman's satisfaction with the procedure.
- Side effects experienced by women [ Time Frame: Every 3 hours from the start of misoprostol administration until complete abortion ]It is a brief questionnaire that records all side effects experienced by women.
- Pain experienced by women [ Time Frame: At the time of discharge, up to 5 days after enrollment ]It is a scale that assesses the acceptability of pain experienced by the woman.
- Complications during induction and after discharge [ Time Frame: Every 3 hours from the start of misoprostol administration, up to 1 month after discharge ]It is a record of complications and their treatment during induction and up to 1 month after discharge.
- Women's perception of acceptability of the procedure [ Time Frame: At discharge, up to 5 days after enrollment ]It is a scale that assesses the acceptability of the procedure for the woman.
- Provider's perception of acceptability of the method [ Time Frame: At study completion, up to 2 years after study enrollment commences ]It is a questionnaire that assesses the acceptability of the method for the provider.
- Total dose of misoprostol administered [ Time Frame: Every 3 hours from start of misoprostol administration to complete abortion ]Count of the total dose of misoprostol administered from the first dose to complete abortion.
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): NCT02235155
|Bukhara Maternity House No. 1|
|Samarkand Perinatal Center|
|Clinic No. 2, Tashkent Medical Academy|
|Principal Investigator:||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|