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

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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

Tracking Information
First Submitted Date December 6, 2012
First Posted Date January 11, 2013
Last Update Posted Date July 9, 2014
Study Start Date December 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 7, 2014)
Rate of successful abortion [ Time Frame: Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose ]
Original Primary Outcome Measures
 (submitted: January 9, 2013)
  • Rate of successful abortion [ Time Frame: Every 3 hours after induction with misoprostol commences, up to 30 hours after the first dose ]
  • 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 ]
  • 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 ]
Change History
Current Secondary Outcome Measures
 (submitted: July 7, 2014)
  • Total dose of misoprostol [ Time Frame: At the time of fetal and placental expulsion, up to 30 hours after the first dose ]
  • Women's satisfaction with the method [ Time Frame: At discharge, up to 5 days after enrollment ]
  • 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 ]
  • 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 ]
  • Providers' acceptability of the method [ Time Frame: After all study procedures complete, at close out, up to 1.5 years after study enrollment commences ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures
 (submitted: January 9, 2013)
  • Total dose of misoprostol [ Time Frame: At the time of fetal and placental expulsion, up to 30 hours after the first dose ]
  • Women's satisfaction with the method [ Time Frame: At discharge, up to 5 days after enrollment ]
  • 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 ]
  • 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 ]
  • Providers' acceptability of the method [ Time Frame: After all study procedures complete, at close out, up to 1.5 years after study enrollment commences ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Armenia
Official Title Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Armenia
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Abortion in Second Trimester
Intervention Not Provided
Study Groups/Cohorts Pregnant women
Pregnant women of 13-22 weeks gestation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 9, 2013)
120
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Armenia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01766388
Other Study ID Numbers 1005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gynuity Health Projects
Study Sponsor Gynuity Health Projects
Collaborators Not Provided
Investigators
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
PRS Account Gynuity Health Projects
Verification Date July 2014