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

Phase 3

Terminated

• Conditions: Abortion, Induced
• Interventions: Drug: Mifepristone+misoprostol; Drug: Placebo+Misoprostol

• Registration Number: NCT00957346
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-11
• Study First Posted: 2009-08-12
• Study Start: 2011-02
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-05
• Last Update Posted: 2011-11-08
• Primary Completion: 2012-01
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mifepristone + Misoprostol	Mifepristone+misoprostol	200 mg mifepristone followed by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.
Misoprostol	Placebo+Misoprostol	Placebo resembling 200mcg mifepristone followed by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses

Primary Outcome Measures

Name	Time	Method
Rate of successful abortion: defined as complete evacuation of uterus using study drug without recourse to any additional intervention.	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.	48 hours

Secondary Outcome Measures

Name	Time	Method
Provision of additional interventions to manage excessive blood loss.	Within 30 days of mifepristone administration.
Total dose of misoprostol.	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	Within 30 days of mifepristone administration.
Pain experienced by the woman	Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.
Women's acceptability of the assigned method	Assessed during exit interview: approximately 48 hours after first dose of misoprostol administration.

Trial Locations

Locations (1)

University of Puerto Rico, University District Hospital Medical Science Campus; 🇵🇷 San Juan, Puerto Rico