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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
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Study Description
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Brief Summary:
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.

Condition or disease
Abortion in Second Trimester

Study Design
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Study Type : Observational
Actual Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Uzbekistan
Bukhara Maternity House No. 1
Bukhara, Uzbekistan
Samarkand Perinatal Center
Samarkand, Uzbekistan
Clinic No. 2, Tashkent Medical Academy
Tashkent, Uzbekistan
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02235155    
Other Study ID Numbers: 1017
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016