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NCT Number: NCT00386282

Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol

This study examined the acceptability and feasibility of introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico; 2 clinics in Baku, Azerbaijan; 3 clinics in Yerevan, Armenia; and 4 clinics in Mexico City. It was hypothesized that the study regimen would be both acceptable and efficacious.

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Key information

Conditions

Abortion, First Trimester

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Family Planning and Sexual Health, Yerevan, Armenia

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About this study

The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone, followed by 800 buccal misoprostol. They later underwent clinic follow-up to determine if their medical abortions were complete. The study assessed the acceptability and feasibility of the above regimen and sought to determine the efficacy and acceptability of buccal administration of misoprostol as well as the acceptability of side effects experienced by women.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Gestation up to 63 days
  • General good health
  • Willingness to provide contact information for follow-up
  • Absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination

Exclusion criteria

  • Ectopic pregnancy
  • Intrauterine device (IUD) in place

Treatment and study plan

mifepristone-misoprostol treatment

Drug

200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone.

Other names: medical abortion

Primary outcomes

  1. efficacy

    Time frame: 15 days

Secondary outcomes

  1. acceptability

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

Acceptability and Feasibility of Medical Abortion in Mexico, Puerto Rico, Armenia and Azerbaijan: A Study of Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days' Gestation

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Oct 11, 2006
Registry last updated
Jul 30, 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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