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

Gynuity Health Projects441 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

441

Conditions

Complete Abortion

Interventions

medical abortionDRUG

pregnancy termination with drugs

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

La Rabta Maternity Hospital

Tunis, Tunisia

Hung Vuong Hospital

Ho Chi Minh City, Vietnam

Outcomes

Primary Outcomes

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

Time frame: one week from initial treatment

Secondary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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