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Completed

NCT Number: NCT02219100

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

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.

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Key information

Conditions

Abortion, First Trimester

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gyumri Maternity Hospital, Gyumri, Armenia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Home administration of 200 mg mifepristone

Drug

Home administration of 200 mg mifepristone

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 18, 2014
Registry last updated
Aug 19, 2014

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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