Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP))

Not Applicable

Completed

• Conditions: Abortion, Induced
• Interventions: Drug: misoprostol+placebo; Drug: mifepristone+misoprostol

• Registration Number: NCT00969982
• 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 120 women in each country comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-18
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 238

Inclusion Criteria

• 14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound)
• 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
misoprostol	misoprostol+placebo	Placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion up to a maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).
mifepristone+misoprostol	mifepristone+misoprostol	200 mg mifepristone followed by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).

Primary Outcome Measures

Name	Time	Method
Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention.	48 hours
Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus.	48 hours

Secondary Outcome Measures

Name	Time	Method
Any heavy bleeding, uterine rupture, or infection requiring additional treatment	start of treatment until discharge
Total dose of misoprostol.	Assessed at time of complete abortion with study drug alone or when total maximum dose given.
Provision of additional interventions to manage excessive blood loss	from start of treatment until discharge
Pain experienced by the woman as self-reported.	Assessed during exit interview.
Women's acceptability of the assigned method	Assessed at exit interview

Trial Locations

Locations (2)

Municipal Clinical Hospital; 🇲🇩 Chishinau, Moldova, Republic of

La Rabta Maternity Hospital; 🇹🇳 Tunis, Tunisia