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COVID-19 Impacted Service Delivery and Research Infrastructure
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| Name | Class |
|---|---|
| Gynuity Health Projects | OTHER |
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This study will assess the impact of providing medication abortion-seeking clients a choice for follow-up in practice. Clients presenting at or less than 63 days pregnant (based on last menstrual period) at the study site for first trimester medication abortion will be invited to participate. We hypothesize that providing clients with flexible follow-up options will improve follow-up rates.
This study is not to assess efficacy or safety of follow-up methods--that has been well established in practice and research. This is to assess choice of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Standard of Care | No Intervention | Participants will be asked to complete follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider. | |
| Group 2: Flexible Follow-Up | Experimental | Participants will be offered three follow-up options, including: 1) follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider; 2) repeat serum beta-hCG testing; 3) repeat multi-level pregnancy test strategy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choice of follow-up option | Other | Participant will be given the opportunity to choose from 3 follow-up options. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent follow-up after medication abortion by group | To compare rates of follow-up among clients who are instructed to come back to the clinic for in-person ultrasound medication abortion follow-up to clients who are given options for follow-up, including in-person ultrasound, repeat serum beta-hCG and MLPT | 5-14 days following mifepristone administration |
| Measure | Description | Time Frame |
|---|---|---|
| Percent follow-up after medication abortion by follow-up type | To compare the overall proportion of follow-up completion among clients choosing their preferred method of follow-up (in-person ultrasound, repeat serum beta-hCG, MLPT strategy) (study period) to clients given only the option for in-person follow-up | 5-14 days following mifepristone administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Health Care | Stanford | California | 94305 | United States |
No data will be shared.
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| Multi-level pregnancy test | Device | The Multi-level pregnancy test (MLPT) strategy involves the use of the MLPT to estimate a pregnant person's baseline hCG range prior to beginning their abortion (i.e. prior to mifepristone administration). A follow-up test is then administered one week later to again estimate the woman's hCG range. A decline in hCG range reliably signifies absence of an ongoing pregnancy. Among clients ≤63 days' LMP at initiation of treatment, this strategy has shown to be highly effective: 100% of clients (n=1487/1487) with a decline in hCG range did not have an ongoing pregnancy and 100% of clients (n=21/21) with an ongoing pregnancy showed steady or increase in hCG range on their follow-up MLPT. |
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