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 |
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.
(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
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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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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2315 Stockton Blvd.
Sacramento, California 95817
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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