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

This study has been terminated.
(poor enrollment)
Sponsor:
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00468299
First received: May 1, 2007
Last updated: June 23, 2011
Last verified: June 2011

May 1, 2007
June 23, 2011
April 2007
December 2008   (final data collection date for primary outcome measure)
Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure. [ Time Frame: 24-48 hrs ] [ Designated as safety issue: No ]
Rate of complete abortion 24-48hrs after receiving medical treatment for early pregnancy failure. [ Time Frame: 24-48 hrs ]
Complete list of historical versions of study NCT00468299 on ClinicalTrials.gov Archive Site
Complete Abortion at One Week [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Complete abortion at one week; uterus demonstrated to be empty on transvaginal ultrasound
Secondary outcomes include: rate of complete abortion at one week, time to expulsion of products of conception, correlation of abortion rates to serum progesterone levels and type of pregnancy failure, number of bleeding days and patient satisfaction [ Time Frame: 3 weeks ]
Not Provided
Not Provided
 
MiMi: A Randomized Trial of Mifepristone and Misoprostol for Treatment of Early Pregnancy Failure
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Early Pregnancy Failure
  • Miscarriage
  • Fetal Demise
  • Anembryonic Pregnancy
  • Drug: Misoprostol and placebo
    Women in this group receive 800 mcg misoprostol plus a placebo
  • Drug: Mifepristone and misoprostol
    This group receives mifepristone 200 mg orally; followed by 800 mcg misoprostol bucally
  • Active Comparator: Misoprostol and placebo
    Women in this arm receive placebo and misoprostol 800 mcg buccally
    Intervention: Drug: Misoprostol and placebo
  • Experimental: Mifepristone and misoprostol
    Womwn in this group receive mifepristone 200 mg orally and misoprostol 800 mcg buccally
    Intervention: Drug: Mifepristone and misoprostol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
December 2008
December 2008   (final data collection date for primary outcome measure)

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)
Female
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00468299
H-25999
Yes
Sarah Betstadt, MD, University of Rochester Medical Center
Boston University
Not Provided
Principal Investigator: Sarah J Betstadt, MD Boston University
Study Director: Olivera Vragovic, MBA Boston University
Boston University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP