MiMi: A Randomized Trial of Mifepristone and Misoprostol for Treatment of Early Pregnancy Failure (MiMi)

June 23, 2011 updated by: Boston University

Treatment of Early Pregnancy Failure

The purpose of this study is to compare two combinations of drugs (mifepristone and misoprostol versus placebo and misoprostol) used for medical treatment for early pregnancy failure. We will compare the two combinations of medications to see which combination makes miscarriage happen faster. We hypothesize that there will be no difference in time to complete miscarriage between the two groups.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The optimal method of treating Early Pregnancy Failure (EPF) is not certain. For many years, surgical management of EPF was the only treatment option. Now there are multiple studies demonstrating the effectiveness of misoprostol for treating EPF. Most of the studies investigating medical treatment of EPF have evaluated efficacy at one week. We have found that many women do not want to wait for one week for an outcome of their medical treatment, and want resolution sooner. This has hampered the widespread utilization of medical therapy in our institution.

We propose a regimen of medical treatment for EPF with expeditious follow-up. We want to demonstrate the relative efficacy of two medication regimens for treatment of EPF by performing a randomized trial. One regimen will be 800μg buccal misoprostol alone and the other regimen will be 200mg mifepristone, orally, in addition to 800μg buccal misoprostol, simultaneously. The primary outcome will be complete abortion rates 24hours after medication administration. We hypothesize that mifepristone will not improve complete abortion rates at 24hrs.

Secondary outcomes include rates of abortion by medical treatment at one week, the indications for surgical intervention, relationship of progesterone levels and type of pregnancy failure to outcomes in the two groups. Another secondary objective is to assess satisfaction with the treatment process at the conclusion of pregnancy termination, and 3 weeks after the beginning of the process.

The majority of studies investigating medical treatment of EPF use vaginal misoprostol, but buccal use is increasing. We will use buccal misoprostol, which is widely used at our institution. We will assess the efficacy of this route of administration as well as assess patient acceptability of this method.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University

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

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age >18yrs, able to read and write English
  • Intrauterine gestations with anembryonic sac between 10 and 45mm or
  • 10-15mm sac with no growth in three days or other radiologic signs of abnormal pregnancy such as irregular sac or debris within the gestational sac
  • An embryonic pole <30mm with no cardiac activity

Exclusion Criteria:

  • Intrauterine gestations with CRL <5mm or >30mm without cardiac activity
  • Incomplete abortion as defined as open cervix and large amount of cramping/bleeding
  • Hemodynamic instability and/or heavy vaginal bleeding
  • Hemoglobin less than or equal to 8
  • Inability to follow-up (ie, lack of transportation or access to telephone)
  • Bleeding disorder or taking anticoagulants
  • Prior medical or surgical treatment of the current pregnancy
  • Obvious Infection
  • Active Lactation
  • Allergy to mifepristone or misoprostol
  • Chronic corticosteroid use
  • Severe gastrointestinal disease (e.g inflammatory bowel disease, severe gastritis)

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Misoprostol and placebo
Women in this arm receive placebo and misoprostol 800 mcg buccally
Drug: Misoprostol and placebo
Women in this group receive 800 mcg misoprostol plus a placebo
Experimental: Mifepristone and misoprostol
Womwn in this group receive mifepristone 200 mg orally and misoprostol 800 mcg buccally
Drug: Mifepristone and misoprostol
This group receives mifepristone 200 mg orally; followed by 800 mcg misoprostol bucally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.
Time Frame: 24-48 hrs
24-48 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Abortion at One Week
Time Frame: 3 weeks
Complete abortion at one week; uterus demonstrated to be empty on transvaginal ultrasound
3 weeks

Collaborators and Investigators

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

Sponsor

Boston University

Investigators

  • Principal Investigator: Sarah J Betstadt, MD, Boston University
  • Study Director: Olivera Vragovic, MBA, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 1, 2007

First Submitted That Met QC Criteria

May 1, 2007

First Posted (Estimate)

May 2, 2007

Study Record Updates

Last Update Posted (Estimate)

July 21, 2011

Last Update Submitted That Met QC Criteria

June 23, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-25999

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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