Mifepristone and Misoprostol for Fetal Demise - Full Text View

Sponsors and Collaborators:	University of Pittsburgh An anonymous Foundation.
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00177372

Purpose

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.

Condition	Intervention	Phase
Early Pregnancy Failure Anembryonic Gestation Fetal Demise	Drug: mifepristone/misoprostol	Phase IV

Drug Information available for: Mifepristone Misoprostol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Mifepristone and Misoprostol for the Treatment of Early Pregnancy Failure: a Pilot Clinical Trial

Further study details as provided by University of Pittsburgh:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
to assess if mifepristone/misoprostol treatment is acceptable to patients with early pregnancy failure [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]
to assess the predictors/indicators for successful mifpristone/misoprostol treatment in patients with early pregnancy failure [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	January 2005
Study Completion Date:	September 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally	Drug: mifepristone/misoprostol mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177372

Locations

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

Sponsors and Collaborators

University of Pittsburgh

An anonymous Foundation.

Investigators

Principal Investigator:

Mitchell D Creinin, MD

Magee-Womens Hospital

More Information

Publications of Results:

Schreiber CA, Creinin MD, Reeves MF, Harwood BJ. Mifepristone and misoprostol for the treatment of early pregnancy failure: a pilot clinical trial. Contraception. 2006 Dec;74(6):458-62. Epub 2006 Sep 7.

Responsible Party:	University of Pittsburgh ( MItchell Creinin, MD )
Study ID Numbers:	Pittirb0409119
Study First Received:	September 12, 2005
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00177372
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Misoprostol
Mifepristone

Additional relevant MeSH terms:

Abortifacient Agents, Steroidal
Contraceptives, Postcoital, Synthetic
Oxytocics
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Gastrointestinal Agents
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists

Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Contraceptives, Postcoital
Luteolytic Agents
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on January 16, 2009