This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,400
200 mg oral mifepristone 800 mcg buccal misoprostol or 400 mcg sublingual misoprostol 24-48 hours after mifepristone
Presidential Women's Center
West Palm Beach, Florida, United States
Family Planning Associates Medical Group
Chicago, Illinois, United States
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States
Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion
Time frame: 7-36 days
Proportion of individual side effects experienced by participants
Time frame: 7-14 days
Proportion of women who determined method acceptable (i.e., overall acceptability of method, time to abortion completion, bleeding, side effects, and pain)
Time frame: 7-14 days
Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began
Time frame: 7-14 days
Average number of missed days of work or school due to the abortion procedure
Time frame: 7-14 days
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Planned Parenthood, Minnesota, North Dakota, South Dakota
Saint Paul, Minnesota, United States
Planned Parenthood of New York City
New York, New York, United States
Planned Parenthood, Central Texas
Waco, Texas, United States
Zhordania Institute of Human Reproduction
Tbilisi, Georgia
Government Medical College (GMC)
Nagpur, India
Naval Nursing Home
Solapur, India
La Rabta Maternity Hospital
Tunis, Tunisia
...and 2 more locations