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Completed

NCT Number: NCT02398838

Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Batumi Maternity House, Batumi, Adjara, Georgia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home administration of 200 mg mifepristone

Drug

Home administration of 200 mg mifepristone.

Other names: Penkrofton

Home or clinic administration of 400 mcg buccal misoprostol

Drug

Home or clinic administration of 400 mcg buccal misoprostol

Primary outcomes

  1. 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

  1. 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.

Other outcomes

  1. Proportion of women who select home-use of mifepristone

    Time frame: 1 week

  2. Proportion of women who select home-use of misoprostol

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 26, 2015
Registry last updated
Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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