Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone

Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone-3 Hour Intervals

This double blinded, placebo-controlled randomized trial will compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800 mcg doses of buccal misoprostol three hours apart. All drugs are administered AT home by the participant.

Study Overview

• Status: Completed
• Conditions: Complete Abortion
• Intervention / Treatment: Drug: medical abortion

• Study Type: Interventional
• Enrollment (Actual): 441
• Phase: Phase 4

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia
    • La Rabta Maternity Hospital
• Vietnam
  • Ho Chi Minh City, Vietnam
    • Hung Vuong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Gestational age < 63 days since LMP, confirmed by ultrasound or clinical assessment.
• General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination.
• Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
• Able to consent to study participation.

Exclusion Criteria:

• Gestational age > 63 days LMP
• Confirmed or suspected ectopic or molar pregnancy
• Contraindications to medical abortion including intra-uterine device (IUD) in place (must be removed before procedure), chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or prostaglandin, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyries.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: mifepristone+misoprostol; 200 mg mifepristone + 800 mcg buccal misoprostol	Drug: medical abortion; pregnancy termination with drugs
EXPERIMENTAL: buccal misoprostol; 2 doses of 800 mcg buccal misoprostol	Drug: medical abortion; pregnancy termination with drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of women with a complete abortion using study drug alone without recourse to surgical intervention	Number of participants with a complete abortion after treatment without recourse to surgical intervention as a measure of efficacy of the study regimens	one week from initial treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of women who indicate that the side effects of buccal misoprostol, administered either alone or in combination with mifepristone, is acceptable in Tunisia and Vietnam	Proportion of women who report the side effects after their treatment to be acceptable as a measure of acceptability with the buccal misoprostol route (with and without mifepristone)	one week from initial treatment
Evaluate whether women administering buccal misoprostol have a complete abortion with study drug and experience any adverse events, at a rate that is similar to other routes of misoprostol administration	To assess the rate of complete uterine evacuation with study drugs alone and rate of any adverse events among participants after use of buccal misoprostol (alone or with mifepristone)as a measure of its utility in early medical abortion compared to other regimens	one week from initial treatment
Measuring the proportion of women who report their medical abortion procedure to be acceptable in Tunisia and Vietnam	Proportion of participants reporting that they found the medical abortion regimen assigned to them to be acceptable	one week from initial treatment
Determining whether women can take both the mifepristone and misoprostol at home on their own by assessing protocol compliance	Proportion of women who report taking mifepristone and misoprostol at home on their own as instructed as a measure of compliance and feasibility of a protocol with at home administration of study drugs	one week from initial treatment

Collaborators and Investigators

• Sponsor: Gynuity Health Projects

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: May 2, 2011
• First Submitted That Met QC Criteria: July 1, 2011
• First Posted (ESTIMATE): July 4, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 20, 2011
• Last Update Submitted That Met QC Criteria: July 18, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: mifepristone; misoprostol; abortion; with gestations > 63 days LMP
• Other Study ID Numbers: 1.2.1