Comparative Effectiveness of Pregnancy Failure Management Regimens

Comparative Effectiveness of Pregnancy Failure Management Regimens

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