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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 January 2016 |
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Main ID: |
NCT02235155 |
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Date of registration:
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29/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Mifepristone and Misoprostol for Midtrimester Termination of Pregnancy in Uzbekistan
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Scientific title:
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Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Uzbekistan |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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135 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02235155 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Uzbekistan
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Contacts
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Name:
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Dilfuza Kurbanbekova, PhD, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Women's Wellness Center, Uzbekistan |
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Name:
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Beverly Winikoff, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Tamar Tsereteli, PhD, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Meet legal criteria to obtain abortion
- Have an ongoing pregnancy of 13-22 weeks gestation
- Be willing to undergo a surgical completion if necessary
- Have no contraindications to study procedures, according to provider
- Be willing and able to consent to procedure, either by reading consent document or by
having consent document read to her
- Be willing to follow study procedures
Exclusion Criteria:
- Known previous transmural uterine incision
- Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications
to the use of mifepristone or misoprostol
- Any contraindications to vaginal delivery, including placenta previa
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Abortion in Second Trimester
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Primary Outcome(s)
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Proportion of abortions that are complete as a measure of efficacy
[Time Frame: At 15 hours after the start of misoprostol administration]
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Secondary Outcome(s)
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Side effects experienced by women
[Time Frame: Every 3 hours from the start of misoprostol administration until complete abortion]
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Total dose of misoprostol administered
[Time Frame: Every 3 hours from start of misoprostol administration to complete abortion]
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Complications during induction and after discharge
[Time Frame: Every 3 hours from the start of misoprostol administration, up to 1 month after discharge]
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Pain experienced by women
[Time Frame: At the time of discharge, up to 5 days after enrollment]
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Provider's perception of acceptability of the method
[Time Frame: At study completion, up to 2 years after study enrollment commences]
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Women's satisfaction with the method
[Time Frame: At discharge, up to 5 days after enrollment]
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Interval of time between induction with misoprostol to complete abortion
[Time Frame: Every 3 hours from the start of misoprostol administration until complete abortion]
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Women's perception of acceptability of the procedure
[Time Frame: At discharge, up to 5 days after enrollment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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