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Completed

NCT Number: NCT00177372

Mifepristone and Misoprostol for Fetal Demise

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.

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Key information

Conditions

Anembryonic Pregnancy Gestation Abnormality Intrauterine Fetal Demise Term

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mifepristone/misoprostol

Drug

mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally

Other names: Mifeprix/Cytotec

Primary outcomes

  1. to determine if medical management with mifepristone and misoprostol for early pregnancy failure is an effective and acceptable treatment

    Time frame: 1-2 weeks

Secondary outcomes

  1. 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

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

    Time frame: 1-2 weeks

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

    Time frame: 1-2 weeks

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Acronym: MIMID

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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