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The primary objective of this study is to document the rates of success and serious complications among women having outpatient medical abortions with 200 mg mifepristone + 800 buccal misoprostol at 64-70 days of gestation.
The study will be conducted at US abortion clinics that have offered medical abortion with 200 mg mifepristone + 800 mcg buccal misoprostol to at least 20 women at 64-70 days of gestation. Designated staff at each site will review clinic records to identify and record data from every patient treated in that gestational week. Once data collection is completed, if the rate of success or serious complications at any clinic is substantially discordant from rates documented in the published literature, we may collect additional data on patients seeking medical abortion at 57-63 days, to aid in explaining results found in the 64-70 days group. In this situation, for each patient in the 64-70 days group, site staff will identify and record data from the next consecutive patient treated with this regimen at 57-63 days.
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| Measure | Description | Time Frame |
|---|---|---|
| Abortion Success | Defined as a complete abortion without use of surgery | 1 week |
| Serious complications | Defined as admission to hospital, receipt of parenteral antibiotics, surgery (laparoscopies, laparotomies, hysterectomies), transfusion, or death | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of ongoing pregnancies | Proportion of ongoing pregnancies after the initially dispensed mife-miso | 1 week |
| Proportion of complete abortions without additional treatment | Proportion of complete abortions without additional treatment other than the initially dispensed mife-miso |
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Inclusion Criteria:
Exclusion Criteria:
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The study will be conducted at US abortion clinics that have offered medical abortion with 200 mg mifepristone + 800 mcg buccal misoprostol to at least 20 women at 64-70 days of gestation. Designated staff at each site will review clinic records to identify and record data from every patient treated in that gestational week.
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Raymond, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Planning Associates- Northwest Chicago | Chicago | Illinois | 60630 | United States | ||
| Family Planning Associates- Downtown Chicago |
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| 1 week |
| Proportion of significant abortion complications | Proportion of significant abortion complications, including diagnosis of receipt of treatment for an abortion-related problem at an emergency department or urgent care center | 1 month |
| Chicago |
| Illinois |
| 60661 |
| United States |