Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled 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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-12-31

Brief Summary

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The purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.

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Detailed Description

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The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of missed abortion. This will be a randomized controlled double-blinded trial of 416 women comparing misoprostol alone to mifepristone plus misoprostol for treatment of missed abortion less than 13 weeks+ 0 days LMP. All women in the trial will undergo routine screening (including ultrasound) and pre-medical induction care per standard practice at the hospital. All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens: 1) STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by 800mcg sublingual misoprostol; 2) STUDY GROUP TWO: placebo followed in 24 hours by 800mcg sublingual misoprostol.

Conditions

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Missed Abortion Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mifepristone-misoprostol regimen

After a woman is determined eligible and signs the informed consent document, she will receive 200 mg mifepristone and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

Mifepristone for treatment of missed abortion

Misoprostol

Intervention Type DRUG

Misoprostol for treatment of missed abortion

Misoprostol alone regimen

After a woman is determined eligible and signs the informed consent document, she will receive a placebo (of same shape and size of mifepristone) and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.

Group Type PLACEBO_COMPARATOR

Misoprostol

Intervention Type DRUG

Misoprostol for treatment of missed abortion

Interventions

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Mifepristone

Mifepristone for treatment of missed abortion

Intervention Type DRUG

Misoprostol

Misoprostol for treatment of missed abortion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ultrasound examination demonstrating:

1. Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR
2. Empty gestational sac with no evidence of incomplete abortion or growth over a 7-day period confirmed by two ultrasounds performed one week apart.
* If fetus exists, fetal size less than 12 weeks+6 days
* Closed cervical os
* Eligible to consent for research according to local regulations

Exclusion Criteria

* Active bleeding at enrollment and/or history of bleeding within the prior week
* Allergies or other contraindications to the use of mifepristone or misoprostol
* Suspected ectopic pregnancy
* History of trophoblastic disease
* Coagulation disorder and/or currently taking anticoagulants
* Any serious medical condition

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes