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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

441 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Complete Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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mifepristone+misoprostol

200 mg mifepristone + 800 mcg buccal misoprostol

Group Type OTHER

medical abortion

Intervention Type DRUG

pregnancy termination with drugs

buccal misoprostol

2 doses of 800 mcg buccal misoprostol

Group Type EXPERIMENTAL

medical abortion

Intervention Type DRUG

pregnancy termination with drugs

Interventions

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medical abortion

pregnancy termination with drugs

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes