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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 71-77 days gestational age | Experimental | Women whose pregnancies are estimated to have a gestational age of 71-77 days. |
|
| 64-70 days gestational age | No Intervention | Women whose pregnancies are estimated to have a gestational age of 64-70 days.( Women in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone followed by misoprostol 24-48 hours later | Drug | 200mg oral mifepristone and 800mcg buccal misoprostol 24-48 hours after mifepristone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7-36 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Individual Side Effects Experienced by Participants | Side effects include diarrhea, nausea, vomiting, fever, chills, headaches, dizziness and/or weakness experienced by participants | 7-14 days |
| Proportion of Women Who Determine Method Acceptable |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD,MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford GYN Center | Hartford | Connecticut | 06106 | United States | ||
| Atlanta Women's Center |
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overall acceptability, time to complete abortion, bleeding, side effects, pain |
| 7-14 days |
| Proportion of Providers Who Determine Method Acceptable | As assessed by service provider semi-structured interviews | 7-36 days |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| John H. Stroger, Jr. Hospital of Cook CountY | Chicago | Illinois | 60612 | United States |
| Family Planning Associates Medical Group | Chicago | Illinois | 60630 | United States |
| Scientific Research Institute of Obstetrics and Gynecology | Baku | Azerbaijan |
| David Gagua Clinic | Tbilisi | Georgia |
| Clínica Comunitaria Santa Catarina | Mexico City | Mexico |
| Hung Vuong Hospital | Ho Chi Minh City | Vietnam |