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

NCT ID: NCT00957346

Last Updated: 2011-11-08

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-01-31

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 20 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.

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 400 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 400 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses.

Misoprostol

Placebo resembling 200mcg mifepristone followed by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses

Group Type PLACEBO_COMPARATOR

Placebo+Misoprostol

Intervention Type DRUG

placebo resembling mifepristone followed 24 hours later by 400 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 400 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses.

Intervention Type DRUG

Placebo+Misoprostol

placebo resembling mifepristone followed 24 hours later by 400 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

* 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

Sponsors

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University of Puerto Rico

OTHER

Sponsor Role collaborator

Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beverly Winkoff, M.D., M.P.H

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Yari Vale-Moreno, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Puerto Rico Department of Obstetrics and Gynecology

Melanie Pena, MPH, MA

Role: STUDY_DIRECTOR

Gynuity Health Projects

Locations

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University of Puerto Rico, University District Hospital Medical Science Campus

San Juan, , Puerto Rico

Site Status

Countries

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Puerto Rico

Other Identifiers

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1.3.2

Identifier Type: -

Identifier Source: org_study_id