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Completed

NCT Number: NCT02235155

Mifepristone and Misoprostol for Midtrimester Termination of Pregnancy in Uzbekistan

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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Key information

Conditions

Abortion in Second Trimester

Sex eligibility

Female

Study type

Observational

Primary location

Bukhara Maternity House No. 1, Bukhara, Uzbekistan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Uzbekistan

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 9, 2014
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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