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

Not Applicable

Completed

• Conditions: Induced Abortion
• Interventions: Drug: mifepristone, misoprostol

• Registration Number: NCT00482209
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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.

Detailed Description

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

1. 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)?

2. Are the side effects with buccal use tolerable for women?

3. Is buccal administration of misoprostol acceptable to women?

4. When given a choice, do women prefer to take misoprostol at home or in the clinic?

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-06-04
• Study First Submitted QC: 2007-06-04
• Study First Posted: 2007-06-05
• Status Verified: 2009-10
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2009-10-09
• Last Update Posted: 2009-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	mifepristone, misoprostol	200mg mifepristone followed by 400mcg misoprostol
2	mifepristone, misoprostol	200mg mifepristone followed by 800mcg misoprostol

Primary Outcome Measures

Name	Time	Method
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).	Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit

Secondary Outcome Measures

Name	Time	Method
Side-effects, acceptability for women	side effects and acceptability recorded at exit interview

Trial Locations

Locations (4)

Maternity House #2; 🇬🇪 Tbilisi, Georgia

Maternity House #4; 🇬🇪 Tbilisi, Georgia

Zhordania Institute of Human Reproduction; 🇬🇪 Tbilisi, Georgia

Hocmon Hospital; 🇻🇳 Ho Chi Minh City, Vietnam