Mifepristone and Misoprostol for Fetal Demise

Condition(s) targeted: Early Pregnancy Failure; Anembryonic Gestation; Fetal Demise

Intervention: mifepristone/misoprostol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
Mitchell D Creinin, MD, Principal Investigator, Affiliation: Magee-Womens Hospital

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.

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

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

Primary outcome: to determine if medical management with mifepristone and misoprostol for early pregnancy failure is an effective and acceptable treatment

Secondary outcome:

to evaluate if the treatment of early pregnancy failure with mifepristone and misoprostol is as effective as induced abortion with these medications

to assess if mifepristone/misoprostol treatment is acceptable to patients with early pregnancy failure

to assess the predictors/indicators for successful mifpristone/misoprostol treatment in patients with early pregnancy failure

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

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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

Magee-Womens Hospital, Pittsburgh, Pennsylvania 15213, United States

Starting date: January 2005
Ending date: September 2005
Last updated: December 13, 2007