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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Abortion, Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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mifepristone+misoprostol

200 mg mifepristone followed by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.

Group Type EXPERIMENTAL

mifepristone+misoprostol

Intervention Type DRUG

single dose of 200 mg mifepristone followed 24 hours later by 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses.

misoprostol

Intervention Type DRUG

placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.

misoprostol

800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.

Group Type EXPERIMENTAL

misoprostol

Intervention Type DRUG

placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.

placebo

Intervention Type DRUG

placebo resembling mifepristone taken 24 hours before 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.

Interventions

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mifepristone+misoprostol

single dose of 200 mg mifepristone followed 24 hours later by 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses.

Intervention Type DRUG

misoprostol

placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.

Intervention Type DRUG

placebo

placebo resembling mifepristone taken 24 hours before 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.

Intervention Type DRUG

Eligibility Criteria

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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)

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes