Comparative Effectiveness of Pregnancy Failure Management Regimens



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:1/16/2019
Start Date:January 2014
End Date:June 15, 2019

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The purpose of the study is to compare the effectiveness of combination treatment
(mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol
(standard of care) for the management of early pregnancy failure.


Inclusion Criteria:

- between 5 and 12 completed weeks gestation

- 18 years or older

- hemodynamically stable

- confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation
(ultrasound examination demonstrates a fetal pole without cardiac activity measuring
between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy
failure)

- willing and able to give informed consent

Exclusion Criteria:

- diagnosis of incomplete or inevitable abortion (absent gestational sac and/or active
bleeding, open cervical os)

- contraindication to mifepristone (chronic corticosteroid administration, adrenal
disease)

- contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or
known allergy to prostaglandin)

- cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)

- most recent hemoglobin <9.5 g/dL

- diagnosis of porphyria

- known clotting defect or receiving anticoagulants

- pregnancy with an intrauterine device (IUD) in place

- breastfeeding during the first 7 days of study participation

- unwilling to comply with the study protocol and visit schedule

- any evidence of viable pregnancy

- possibility of ectopic pregnancy

- known or suspected pelvic infection

- concurrent participation in any other interventional trial
We found this trial at
3
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Courtney Schreiber, MD, MPH
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Mitchell Creinin, MD
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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Sacramento, CA
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