Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP)

Gynuity Health Projects550 enrolled

Overview

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of mifepristone 200 mg is as effective and acceptable at inducing an abortion compared with misoprostol taken sublingually (under the tongue). Women presenting for voluntary termination of intrauterine pregnancy with gestational ages of \<63 days will be offered the option of participating in the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

550

Conditions

Abortion, Induced

Interventions

MisoprostolDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Gestational age less than or equal to 63 days * General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination; and * Willing to provide an address and/or telephone number for purposes of follow-up. Exclusion Criteria: * Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass * IUD in place * Chronic renal failure * Concurrent long-term corticosteroid therapy * History of allergy to mifepristone, misoprostol or other prostaglandin * Hemorrhagic disorders or concurrent anticoagulant

Outcomes

Primary Outcomes

Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration

Time frame: July 2007-March 2009

Secondary Outcomes

Side effects experienced

Time frame: July 2007- March 2009