Abortion, Medical
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Gynuity Health Projects
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Women at 64-70 days of gestation * Received 200 mg mifepristone + 800 mcg buccal misoprostol for a medical abortion
Exclusion criteria
* Does not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abortion Success | 1 week | Defined as a complete abortion without use of surgery |
| Serious complications | 1 month | Defined as admission to hospital, receipt of parenteral antibiotics, surgery (laparoscopies, laparotomies, hysterectomies), transfusion, or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of ongoing pregnancies | 1 week | Proportion of ongoing pregnancies after the initially dispensed mife-miso |
| Proportion of complete abortions without additional treatment | 1 week | Proportion of complete abortions without additional treatment other than the initially dispensed mife-miso |
| Proportion of significant abortion complications | 1 month | Proportion of significant abortion complications, including diagnosis of receipt of treatment for an abortion-related problem at an emergency department or urgent care center |
Countries
United States
Outcome results
None listed