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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00468299
Recruitment Status : Terminated (poor enrollment)
First Posted : May 2, 2007
Results First Posted : July 21, 2011
Last Update Posted : July 21, 2011
Information provided by:
Boston University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Early Pregnancy Failure Miscarriage Fetal Demise Anembryonic Pregnancy Drug: Misoprostol and placebo Drug: Mifepristone and misoprostol Not Applicable

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  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Early Pregnancy Failure
Study Start Date : April 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure. [ Time Frame: 24-48 hrs ]

Secondary Outcome Measures :
  1. Complete Abortion at One Week [ Time Frame: 3 weeks ]
    Complete abortion at one week; uterus demonstrated to be empty on transvaginal ultrasound

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00468299

United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Principal Investigator: Sarah J Betstadt, MD Boston University
Study Director: Olivera Vragovic, MBA Boston University


Responsible Party: Sarah Betstadt, MD, University of Rochester Medical Center Identifier: NCT00468299     History of Changes
Other Study ID Numbers: H-25999
First Posted: May 2, 2007    Key Record Dates
Results First Posted: July 21, 2011
Last Update Posted: July 21, 2011
Last Verified: June 2011

Keywords provided by Boston University:

Additional relevant MeSH terms:
Abortion, Spontaneous
Fetal Death
Pregnancy Complications
Pathologic Processes
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents