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
  Purpose

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 Intervention
Early Pregnancy Failure
Miscarriage
Fetal Demise
Anembryonic Pregnancy
Drug: Misoprostol and placebo
Drug: Mifepristone and misoprostol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Early Pregnancy Failure

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 16
Study Start Date: April 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468299

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

Publications:

Responsible Party: Sarah Betstadt, MD, University of Rochester Medical Center
ClinicalTrials.gov Identifier: NCT00468299     History of Changes
Other Study ID Numbers: H-25999
Study First Received: May 1, 2007
Results First Received: April 12, 2011
Last Updated: June 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
early
pregnancy
failure
mifepristone
misoprostol
buccal
miscarriage
fetal
demise
anembryonic
progesterone

Additional relevant MeSH terms:
Abortion, Spontaneous
Pregnancy Complications
Mifepristone
Misoprostol
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
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
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on July 31, 2014