Medical Abortion With Mifepristone + Misoprostol (13

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

PHASE4

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-05-31

Brief Summary

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A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.

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Detailed Description

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Conditions

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Complete Uterine Evacuation After Use of Study Drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Mifepristone at home 24 hours before miso dosing starts

All women will receive study packet one containing mifepristone to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing a placebo. Simultaneously, they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours.

Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled.

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol

Mifepristone and first dose of misoprostol simultaneously.

Will receive study packet one containing placebo to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing mifepristone. Simultaneously they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours.

Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled. The procedure will be considered complete once both the fetus and placenta are expelled.

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol

Interventions

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Mifepristone

200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol

Intervention Type DRUG

Misoprostol

200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Closed cervical os and no vaginal bleeding
* Live fetus at time of presentation for service
* No contraindications to medical abortion and study procedures, according to provider
* Able to consent to participate in the study, either by reading consent document or by having consent document read to her and sign informed consent
* Willing to follow study procedures

Exclusion Criteria

* Known previous transmural uterine incision
* \> 5 parity
* Signs and symptoms of infection
* 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