Status:
TERMINATED
MiMi: A Randomized Trial of Mifepristone and Misoprostol for Treatment of Early Pregnancy Failure
Lead Sponsor:
Boston University
Conditions:
Early Pregnancy Failure
Miscarriage
Eligibility:
FEMALE
18-64 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00468299
Start Date
April 1 2007
End Date
December 1 2008
Last Update
July 21 2011
Active Locations (1)
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1
Boston University
Boston, Massachusetts, United States, 02118