Mifepristone and Misoprostol for Fetal Demise (MIMID)

University of Pittsburgh

Status and phase

Completed

Phase 4

Conditions

Intrauterine Fetal Demise Term

Anembryonic Pregnancy

Gestation Abnormality

Treatments

Drug: mifepristone/misoprostol

Study type

Interventional

Funder types

Other

Identifiers

NCT00177372

Pittirb0409119

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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