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This is a prospective study to evaluate if successful completion of a medication abortion in patients with very early pregnancy can be detected with a urine pregnancy test at 2 weeks instead of 4 weeks. Additionally, the resolution of pregnancy symptoms in these patients will be characterized. Enrolled participants will take take weekly pregnancy tests and complete weekly questionnaires on their pregnancy symptoms for 4 weeks after their medication abortion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Early Pregnancy | Participants with early pregnancy ≤ 42 days by last menstrual period or ultrasound undergoing a medication abortion will be enrolled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weekly high-sensitivity urine pregnancy tests | Diagnostic Test | Participants will take a high-sensitivity urine pregnancy test at home weekly for up to 4 weeks compared to the taking just one home urine pregnancy test at 4-5 weeks. Participants will also complete short weekly questionnaires on their pregnancy symptoms and follow-up care. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with negative high-sensitivity urine pregnancy test at 2 weeks | To estimate the proportion of negative high-sensitivity urine pregnancy tests in participants with very early pregnancy and a complete abortion at 2 weeks after taking Mifepristone and compare this proportion to the proportion of negative high-sensitivity urine pregnancy tests in participants with very early pregnancy and a complete abortion at 4 weeks | From time of taking Mifepristone to negative pregnancy test or 4-5 weeks of questionnaires |
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution of pregnancy symptoms | To compare the timing of pregnancy symptom resolution per patient report on weekly questionnaires with the timing of a negative high-sensitivity urine pregnancy test result | From time of taking Mifepristone to negative pregnancy test or 4-5 weeks of questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
- Privacy or safety concerns about filling out the surveys
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This study will enroll patients who meet the inclusion criteria at clinical sites in Washington, Georgia, and Maryland.
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| Name | Affiliation | Role |
|---|---|---|
| Lyndsey Benson, MD, MS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carafem | Atlanta | Georgia | 30309 | United States | ||
| Carafem |
Access to study IPD will not be shared for this study due to the sensitive, private nature of the clinical care received by participants. Participant safety and confidentiality is of utmost importance for this study.
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|
| Chevy Chase |
| Maryland |
| 20815 |
| United States |
| Cedar River Clinics | Renton | Washington | 98055 | United States |