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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01766388
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : July 9, 2014
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Study Description
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Brief Summary:
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.

Condition or disease
Abortion in Second Trimester

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Armenia
Study Start Date : December 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013
Groups and Cohorts
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Group/Cohort
Pregnant women
Pregnant women of 13-22 weeks gestation


Outcome Measures
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Primary Outcome Measures :
  1. Rate of successful abortion [ Time Frame: Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All women presenting to a study clinic in Yerevan, Armenia for voluntary termination of intrauterine pregnancy with gestational ages of 13-22 weeks
Criteria

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)
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): NCT01766388


Locations
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Armenia
State Medical University
Yerevan, Armenia, 0025
Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology
Yerevan, Armenia, 0078
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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Principal Investigator: Ruzanna Abrahamyan, MD Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology
Principal Investigator: Gayane Abrahamyan, MD, PhD State Medical University
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
More Information
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01766388    
Other Study ID Numbers: 1005
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014