Official Title: “Mifepristone and Misoprostol for the Treatment of Early Pregnancy Failure: a Pilot Clinical Trial”

This is a pilot clinical trial to evaluate whether the medical management of early pregnancy failure with mifepristone and misoprostol is an effective and acceptable treatment. Subjects with early pregnancy failure receive mifepristone followed 24 hours later by vaginal misoprostol for medical management. Subjects then return on study day 3 for a repeat ultrasound to assess passage of pregnancy tissue. subjects who still have a gestational sac present at Day 3 receive a second dose of vaginal misoprostol. All subjects have a follow-up at Day 15, by phone for those who passed the pregnancy with the first dose of misoprostol, and in person for those who received a second dose. Questionnaires are administered at the beginning and end of the study to determine acceptability.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: mifepristone/misoprostol
  • mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally

Primary Measures

• to determine if medical management with mifepristone and misoprostol for early pregnancy failure is an effective and acceptable treatment
  • Time Frame: 1-2 weeks
    Safety Issue?: No

Secondary Measures

• to evaluate if the treatment of early pregnancy failure with mifepristone and misoprostol is as effective as induced abortion with these medications
  • Time Frame: 1-2 weeks
    Safety Issue?: No
• to assess if mifepristone/misoprostol treatment is acceptable to patients with early pregnancy failure
  • Time Frame: 1-2 weeks
    Safety Issue?: No
• to assess the predictors/indicators for successful mifpristone/misoprostol treatment in patients with early pregnancy failure
  • Time Frame: 1-2 weeks
    Safety Issue?: No

• Inclusion Criteria: healthy hemodynamically stable females with a non-viable pregnancy
-

Exclusion Criteria:

• orthostatic hypotension, contraindication to either mifepristone or misoprostol, treatment during current pregnancy to provide surgical or medical evacuation of the uterus, evidence of ovarian hyperstimulation syndrome, known or suspected pelvic infection,known or suspected clotting defect or receiving anticoagulants, cardiovascular disease, current breastfeeding, pregnancy with and IUD in situ, current participation in another clinical trial, prior participation in this trial, suspected or confirmed endometrial AV malformation, clinical indication requiring the karyotyping of products of conception

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

Mitchell D Creinin, MD Principal Investigator Magee-Womens Hospital  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00177372

Study ID Number: Pittirb0409119

ClinicalTrials.gov Identifier: NCT00177372

Health Authority: United States: Food and Drug Administration