Comparative Effectiveness of Pregnancy Failure Management Regimens (PreFaiR)

University of Pennsylvania

Status and phase: Completed; Phase 3

Conditions: Spontaneous Abortion

Treatments: Drug: Misoprostol; Drug: Mifepristone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02012491

818434

1R01HD071920-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

misoprostol plus mifepristone

Active Comparator group

Description:

800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior

Treatment:

Drug: Mifepristone

Drug: Misoprostol

misoprostol

Active Comparator group

Description:

800 micrograms of vaginal misoprostol alone

Treatment:

Drug: Misoprostol