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Completed

NCT Number: NCT00482209

Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation

This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.

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Key information

Conditions

Induced Abortion

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maternity House #2, Tbilisi, Georgia

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About this study

The goal of this study is to provide answers to the following four questions:

  • Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)?
  • Are the side effects with buccal use tolerable for women?
  • Is buccal administration of misoprostol acceptable to women?
  • When given a choice, do women prefer to take misoprostol at home or in the clinic?

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women 18 years or over presenting for abortion services who consent to participate
  • good general health
  • assessed by a clinician to have an intrauterine pregnancy less than 64 days LMP on Study Day 1 and to be eligible for medical abortion
  • Have ready access to a telephone and emergency transportation;
  • Be willing to provide an address and/or telephone number for purposes of follow-up

Exclusion criteria

  • Conditions which contraindicate the use of mifepristone or misoprostol
  • Women presenting for medical abortion who do not consent to participate

Treatment and study plan

Mifepristone, misoprostol

Drug

200mg mifepristone followed by 400mcg misoprostol 36-48 hours later

Primary outcomes

  1. Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22).

    Time frame: Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit

Secondary outcomes

  1. Side-effects, acceptability for women

    Time frame: side effects and acceptability recorded at exit interview

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 5, 2007
Registry last updated
Oct 12, 2009

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

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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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