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

January 11, 2019 updated by: Gynuity Health Projects
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

416

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Nacional Profesor Alejandro Posadas
  • Gabon
      • Libreville, Gabon
        • CHU Libreville
  • Mexico
      • Tlalnepantla, Mexico
        • Hospital General Valle Ceylan
  • Pakistan
      • Karachi, Pakistan
        • Agha Khan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Mifepristone
Mifepristone for treatment of missed abortion
Drug: Misoprostol
Misoprostol for treatment of missed abortion
Placebo Comparator: 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.
Drug: Misoprostol
Misoprostol for treatment of missed abortion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of successful evacuation of the uterus
Time Frame: 1 week after treatment
uterine evacuation without the need for uterine aspiration or other surgery
1 week after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of successful evacuation without any additional intervention
Time Frame: 1 week after treatment
uterine evacuation without the need for vacuum aspiration, additional uterotonics or other intervention
1 week after treatment
Excessive bleeding or a complication for which a woman received treatment
Time Frame: 30 days after treatment
30 days after treatment
Induction expulsion interval after misoprostol administration
Time Frame: one week follow-up
time interval between misoprostol administration and the expulsion
one week follow-up
Acceptability of assigned method to women
Time Frame: one week follow-up
one week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

January 9, 2015

First Submitted That Met QC Criteria

January 14, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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