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...
Date First Received: May 1, 2007
Last Updated: October 3, 2008
Verified by: Boston University, October 2008
Clinical Trial Phase: N/A | Start Date: April 2007
Overall Status: Terminated
Estimated Enrollment: 108
Brief Summary
Official Title: “Treatment of Early Pregnancy Failure”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: December 2008
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: mifepristone
- 200 mg mifepristone given along with 800 mcg misoprostol
- Drug: placebo
- this group does not receive mifepristone
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: 1
- Experimental: 2
- Receives mifepristone and misoprostol
Outcome Measures for this Clinical Trial
Primary Measures
- Rate of complete abortion 24-48hrs after receiving medical treatment for early pregnancy failure.
- Time Frame: 24-48 hrs
Safety Issue?: No
- Time Frame: 24-48 hrs
Secondary Measures
- 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
Safety Issue?: Yes
- Time Frame: 3 weeks
Criteria for Participation in this Clinical Trial
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)
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 64 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Boston University
Overall Clinical Trial Officials and Contacts
Sarah J Betstadt, MD Principal Investigator Boston University
Related Publications
References
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Wagaarachchi PT, Ashok PW, Narvekar N, Smith NC, Templeton A. Medical management of early fetal demise using a combination of mifepristone and misoprostol. Hum Reprod. 2001 Sep;16(9):1849-53.
Zhang J, Gilles JM, Barnhart K, Creinin MD, Westhoff C, Frederick MM; National Institute of Child Health Human Development (NICHD) Management of Early Pregnancy Failure Trial. A comparison of medical management with misoprostol and surgical management for early pregnancy failure. N Engl J Med. 2005 Aug 25;353(8):761-9.
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Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00468299
Study ID Number: H-25999
ClinicalTrials.gov Identifier: NCT00468299
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
