Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation

Not Applicable

Completed

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

• Registration Number: NCT00286208
• Lead Sponsor: Gynuity Health Projects

Brief Summary

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally.

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

1. Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral misoprostol up to 63 days since the last menstrual period (LMP)?

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

3. Is sublingual administration of misoprostol acceptable to women?

4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-02-01
• Study First Submitted QC: 2006-02-01
• Study First Posted: 2006-02-03
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-18
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1443

Inclusion Criteria

• Women presenting for medical abortion who consent to participate
• Possibility of final gestational age of less than or equal to 63 days
• General good health
• Willing to provide contact information 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
Oral Misoprostol	Mifepristone, misoprostol	Misoprostol administered orally
Sublingual Misoprostol	Mifepristone, misoprostol	400 mcg of sublingual misoprostol

Primary Outcome Measures

Name	Time	Method
Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.	2 weeks after mifepristone administration

Secondary Outcome Measures

Name	Time	Method
Acceptability for women	2 weeks
Side effects	48 hours

Trial Locations

Locations (9)

Centre de Planification Familiale la Bardo; 🇹🇳 Tunis, Tunisia

Private clinic; 🇹🇳 Tunis, Tunisia

MoH Ankara Etlik Maternity and Gyneacological Training Hospital; 🇹🇷 Ankara, Turkey

Dr. Zekai Tahir Burak Women's Health Training and Research Hospital; 🇹🇷 Ankara, Turkey

Centre de Planification Familiale de l'Ariana; 🇹🇳 Ariana, Tunisia

Maternité de La Rabta; 🇹🇳 Tunis, Tunisia

State University of Medicine and Pharmacy; 🇲🇩 Chisinau, Moldova, Republic of

Haydarpaşa Numune Training and Research Hospital Family Planning Clinic; 🇹🇷 Istanbul, Turkey

Ege Maternity and Gyneacological Training and Research Hospital; 🇹🇷 Izmir, Turkey