To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48 hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77 days' compared to women 64-70 days' LMP.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
719
200mg oral mifepristone and 800mcg buccal misoprostol 24-48 hours after mifepristone
Hartford GYN Center
Hartford, Connecticut, United States
Atlanta Women's Center
Atlanta, Georgia, United States
John H. Stroger, Jr. Hospital of Cook CountY
Chicago, Illinois, United States
Family Planning Associates Medical Group
Chicago, Illinois, United States
Efficacy as determined by the proportion of successful terminations without surgical intervention (suction curettage or D&C) for any reason
Efficacy of medical abortion in the later first trimester as determined by the proportion of successful terminations without surgical intervention (suction curettage or D\&C) for any reason
Time frame: 7-36 days
Proportion of Individual Side Effects Experienced by Participants
Side effects include diarrhea, nausea, vomiting, fever, chills, headaches, dizziness and/or weakness experienced by participants
Time frame: 7-14 days
Proportion of Women Who Determine Method Acceptable
overall acceptability, time to complete abortion, bleeding, side effects, pain
Time frame: 7-14 days
Proportion of Providers Who Determine Method Acceptable
As assessed by service provider semi-structured interviews
Time frame: 7-36 days
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Scientific Research Institute of Obstetrics and Gynecology
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David Gagua Clinic
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Clínica Comunitaria Santa Catarina
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Hung Vuong Hospital
Ho Chi Minh City, Vietnam