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| Name | Class |
|---|---|
| safe2choose | UNKNOWN |
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Serial use of urine multi-level pregnancy tests (MLPTs) has been shown to be a reliable and efficient strategy for excluding ongoing pregnancy after medical abortion at ≤ 63 days of gestation. This pilot project will assess whether MLPTs can enhance the quality of remote medical abortion services through enabling women to reliably ascertain their abortion outcomes at home sooner than would otherwise have been the case.
safe2choose provides remote medical abortion services through the Internet (information, counselling and access to abortion pills) in a growing number of countries worldwide. safe2choose will collaborate with Gynuity Health Projects to pilot the utility of MLPTs for home follow-up as part of its remote medical abortion services.
As safe2choose does not have a physical office, the location of the sponsor's office is listed in this entry as the study location. Women from the United States are NOT eligible to enroll.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MLPT | Experimental | Multi-level pregnancy test |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-level pregnancy test | Device | Study participants will be instructed to perform a baseline MLPT immediately prior to administering the first dose of abortion medication and a second MLPT one week later to ascertain the follow-up hCG range. Any woman who obtains a stable or increasing hCG result, when comparing the baseline test result with the follow-up test result, will be instructed to contact safe2choose. Any woman who obtains a decrease in her hCG range, when comparing the baseline test result with the follow-up test result, will be informed that her abortion was a success and she is no longer pregnant. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women who successfully receive the MLPTs | 1 week after mailing the MLPTs | |
| Proportion of women who use the MLPTs to determine their abortion outcome | 2 weeks after receiving medical abortion package | |
| Proportion of women able to use MLPTs on their own without guidance or instruction from providers | 2 weeks after receiving medical abortion package | |
| Proportion of women who take action based on the interpretation of their test results | 2 weeks after receiving medical abortion package | |
| Proportion of women who are satisfied with using MLPTs | 2 weeks after receiving medical abortion package |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of all eligible safe2choose clients who elect to participate in the study | 0 days after recruitment | |
| Proportion of women who find the MLPT instructions (written and video) to be helpful tools | 2 weeks after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erica Chong, MPH | Gynuity Health Projects | Principal Investigator |
| Jennifer Blum, MPH | Gynuity Health Projects | Principal Investigator |
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynuity Health Projects | New York | New York | 10010 | United States |
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