Comparative Effectiveness of Pregnancy Failure Management Regimens

• Status: Completed
• Trial end date: 2019-06-15
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Mifepristone; Misoprostol

Criteria

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