Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia

Overview

This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in the eastern and western regions of the country of Georgia. It was hypothesized that home use of mifepristone and buccal administration of misoprostol would be both acceptable and efficacious.

Full Title of Study: “Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia: A Study of 400 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 63 Days Gestation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2012

Detailed Description

The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone. Two days later they took 400 mcg buccal misoprostol, with the option of doing so in the clinic or at home. They underwent clinic follow-up 12-15 days after taking mifepristone to determine if their medical abortions were complete. The study assessed the regimen's efficacy, women's preferences regarding where to administer the medications, and the acceptability of buccal misoprostol and of side effects that accompanied women's medical abortions.

Interventions

  • Drug: Home administration of 200 mg mifepristone
    • Home administration of 200 mg mifepristone.
  • Drug: Home or clinic administration of 400 mcg buccal misoprostol
    • Home or clinic administration of 400 mcg buccal misoprostol

Arms, Groups and Cohorts

  • Experimental: Home administration of mifepristone
    • Home administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.
  • Active Comparator: Clinic administration of mifepristone
    • Clinic administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • At least 18 years old – In 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 – 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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gynuity Health Projects
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Beverly Winikoff, MD, MPH, Principal Investigator, Gynuity Health Projects

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