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Completed

NCT Number: NCT01766388

Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Armenia

The primary goal of this study is to examine the efficacy and feasibility of a mifepristone combined with misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Armenia.

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Key information

Conditions

Abortion in Second Trimester

Sex eligibility

Female

Study type

Observational

Primary location

Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology, Yerevan, Armenia

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About this study

Women who were deemed eligible for the study by the provider gave informed consent. They took 200 mg of mifepristone orally at the study clinic. In 24-44 hours, they returned to the clinic for induction with misoprostol. They were admitted as inpatients at the clinic and took 400 mcg of buccal misoprostol every 3 hours until the fetus and placenta were expelled. If there was no full expulsion after 10 doses of misoprostol, the provider used their discretion to determine the appropriate clinical course of action. After responding to questions about their experience with the procedure, women were discharged from the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnancy of 13-22 weeks' gestation
  • Good general health
  • Meeting legal criteria to obtain abortion
  • Presenting with closed cervical os and no vaginal bleeding
  • Live fetus at time of presentation for service
  • Willingness to undergo a surgical completion if necessary
  • No contraindications to study procedures, according to provider
  • Woman willing and able to consent to procedure, either by reading consent document or by having consent document read to her
  • Willingness 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
  • Parity greater than 5
  • Any contraindications to vaginal delivery, including placenta previa
  • Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)

Treatment and study plan

Primary outcomes

  1. Rate of successful abortion

    Time frame: Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose

Secondary outcomes

  1. Total dose of misoprostol

    Time frame: At the time of fetal and placental expulsion, up to 30 hours after the first dose

  2. Women's satisfaction with the method

    Time frame: At discharge, up to 5 days after enrollment

  3. Side effects

    Time frame: Every 3 hours, starting from the first dose of misoprostol, up to fetal and placental expulsion or 30 hours after the first dose, whichever occurs first

  4. Women's acceptability of the side effects, buccal administration of misoprostol, and duration of procedure

    Time frame: At discharge, up to 5 days after enrollment

  5. Providers' acceptability of the method

    Time frame: After all study procedures complete, at close out, up to 1.5 years after study enrollment commences

  6. Complications including heavy bleeding, uterine rupture, or infection requiring additional treatment

    Time frame: Every 3 hours, starting from the first dose of misoprostol, up to fetal and placental expulsion, or 30 hours after the first dose, whichever occurs first

  7. Induction to fetal expulsion interval

    Time frame: Time from administration of first misoprostol dose to expulsion of the fetus, up to 30 hours after the first dose

  8. Induction to fetal and placental expulsion interval

    Time frame: Time from administration of first misoprostol dose to expulsion of the fetus and placenta, up to 30 hours after the first dose

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 Armenia

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2013
Registry last updated
Jul 9, 2014

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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