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Clinical Trials/NCT02219100
NCT02219100
Completed
Not Applicable

Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus

Gynuity Health Projects5 sites in 2 countries613 target enrollmentNovember 2010
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ConditionsAbortion, First Trimester
InterventionsHome administration of 200 mg mifepristone
DrugsHome administration of 200 mg mifepristone

Overview

Phase
Not Applicable
Intervention
Home administration of 200 mg mifepristone
Conditions
Abortion, First Trimester
Sponsor
Gynuity Health Projects
Enrollment
613
Locations
5
Primary Endpoint
Proportion of abortions that are complete without surgical intervention (unit: percent).
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in Armenia and Azerbaijan. It was hypothesized that home use of mifepristone and misoprostol, and buccal administration of misoprostol, would be both acceptable to women and efficacious.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
November 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Gynuity Health Projects
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •18 years or older
  • •Good general health
  • •Living or working close to the study site
  • •Intrauterine pregnancy less than 64 days gestation
  • •Willing and able to sign consent forms
  • •Eligible for medical abortion according to the clinician's assessment
  • •Ready access to a telephone and emergency transportation
  • •Willing to provide an address and/or telephone number for purposes of follow-up
  • •Agree to comply with the study procedures and visit schedule

Exclusion Criteria

  • •Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
  • •IUD in place (IUD must be removed first)
  • •Chronic renal failure
  • •Concurrent long-term corticosteroid therapy
  • •History of allergy to mifepristone, misoprostol or other prostaglandin
  • •Hemorrhagic disorders or concurrent anticoagulant therapy
  • •Inherited porphyrias
  • •Other serious physical or mental health conditions

Arms & Interventions

Home administration of mifepristone

This arm consisted of women who chose home administration of 200 mg mifepristone.

Intervention: Home administration of 200 mg mifepristone

Outcomes

Primary Outcomes

Proportion of abortions that are complete without surgical intervention (unit: percent).

Time Frame: 15 days

Percentage of women with complete abortion without the need of a surgical intervention.

Secondary Outcomes

  • Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent).(15 days)

Study Sites (5)

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