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

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston University
• Treatments: Mifepristone; Misoprostol

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)