Comparative Effectiveness of Pregnancy Failure Management Regimens

Completed · Phase 3

Conditions studied: Spontaneous Abortion

In brief

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.

Key facts

Study ID

NCT02012491

Run by

University of Pennsylvania

People needed

300

Starts

2014-01-01

Expected to finish

2019-06-15

Last updated by the study team

2019-07-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, Davis Medical Center — Sacramento, California, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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