MiMi: A Randomized Trial of Mifepristone and Misoprostol for Treatment of Early Pregnancy Failure
Stopped early · Not applicable · Has a placebo group
Conditions studied: Early Pregnancy Failure, Miscarriage, Fetal Demise, Anembryonic Pregnancy
In brief
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.
Key facts
- Study ID
- NCT00468299
- Run by
- Boston University
- People needed
- 16
- Starts
- 2007-04-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2011-07-21
Who can join
Age: 18 and older, up to 64. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Boston University — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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