Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial

Not Applicable

Completed

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

• Registration Number: NCT00784186
• 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 260 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-31
• Study First Posted: 2008-11-02
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-18
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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
mifepristone+misoprostol	mifepristone+misoprostol	200 mg mifepristone followed by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.
mifepristone+misoprostol	misoprostol	200 mg mifepristone followed by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.
misoprostol	misoprostol	800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.
misoprostol	placebo	800 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 using study drug without recourse to any additional intervention.	24 hours

Secondary Outcome Measures

Name	Time	Method
Rate of fetal expulsion: defined as fetal expulsion with study drug alone.	24 hours
Induction-to-abortion interval	Time elapsed between administration of the first misoprostol dose until expulsion of the fetus.
Total dose of misoprostol.	Assessed at time of complete abortion with study drug alone or when total maximum dose given.
Pain experienced by the woman as self-reported.	Assessed during exit interview.

Trial Locations

Locations (2)

National Ob-Gyn Hospital; 🇻🇳 Hanoi, Vietnam

Hung Vuong Hospital; 🇻🇳 Ho Chi Minh City, Vietnam