Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP)

Phase 3TerminatedNCT00957346

Gynuity Health Projects20 enrolled

Overview

The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 20 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Abortion, Induced

Interventions

Mifepristone+misoprostolDRUG

single dose of 200 mg mifepristone followed 24 hours later by 400 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses.

Placebo+MisoprostolDRUG

placebo resembling mifepristone followed 24 hours later by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Meet legal criteria to obtain abortion * Present with closed cervical os and no vaginal bleeding * Live fetus at time of presentation for service * Have no contraindications to study procedures, according to provider * Be able to consent to procedure, either by reading consent document or by having consent document read to her * Be willing to follow study procedures Exclusion Criteria: * Known previous transmural uterine incision * Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol * Any contraindications to vaginal delivery, including placenta previa * Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)

Locations (1)

University of Puerto Rico, University District Hospital Medical Science Campus

San Juan, Puerto Rico

Outcomes

Primary Outcomes

Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention.

Time frame: every 3 hours

Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus; approximately 10-24 hours.

Time frame: 48 hours

Secondary Outcomes

Provision of additional interventions to manage excessive blood loss.

Time frame: Within 30 days of mifepristone administration.

Total dose of misoprostol.

Time frame: Assessed at time of complete abortion with study drug alone or when total maximum dose given: approximately 10-24 hours after first dose of misoprostol administration.

Any heavy bleeding, uterine rupture, or infection requiring additional treatment

Time frame: Within 30 days of mifepristone administration.

Pain experienced by the woman

Time frame: Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.

Women's acceptability of the assigned method

Time frame: Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.

Data from ClinicalTrials.gov

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