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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
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
Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment.
Time frame: Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done
Gestational Sac Expulsion by the Second Follow-up Visit at Day 8
Time frame: Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)
Gestational Sac Expulsion by the 30-day Telephone Call
Time frame: 30 Days
Uterine Asperation
Surgical removal of the miscarriage.
Time frame: 30 Days
Frequency of Serious Adverse Events Between Study Arms.
Time frame: 30 days
Adverse Event Reported by Participants
Time frame: 30 Days
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