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

August 18, 2014 updated by: Gynuity Health Projects
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

613

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Armenia
      • Gyumri, Armenia
        • Gyumri Maternity Hospital
      • Vanadzor, Armenia
        • Vanadzor Hospital #1
  • Azerbaijan
      • Gandja, Azerbaijan
        • Antenatal Clinic
      • Gandja, Azerbaijan
        • Family planning center
      • Zaqatala, Azerbaijan
        • Gynecology Department of the Central Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home administration of mifepristone
This arm consisted of women who chose home administration of 200 mg mifepristone.
Drug: Home administration of 200 mg mifepristone
Home administration of 200 mg mifepristone
No Intervention: Clinic administration of mifepristone
This arm consisted of women who underwent clinic administration of 200 mg mifepristone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent).
Time Frame: 15 days
Woman's satisfaction with her medical abortion procedure and side effects experienced.
15 days

Other Outcome Measures

Outcome Measure
Time Frame
Proportion of Women Who Select Home-use of Mifepristone
Time Frame: 1 week
1 week
Proportion of Women Who Select Home-use of Misoprostol
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

Investigators

  • Principal Investigator: Rena Bagirova, MD, Antenatal Clinic
  • Principal Investigator: Mehriban Huseynova, MD, Gynecology Department of the Central Regional Hospital
  • Principal Investigator: Aram Avalyan, MD, Vanadzor Hospital #1
  • Principal Investigator: Alla Minasyan, MD, Gyumri Maternity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Estimate)

August 19, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.2.3.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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