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This randomized study will examine the effectiveness of two types of pregnancy tests (a semi-quantitative test and a high sensitivity test) to identify continuing pregnancy at home at various time points after early medical abortion. The first test a semi-quantitative panel test marketed under the brand name dBest (AmeriTek, Seattle WA, USA). This urine-based, one-step kit has been used in two previous studies in Vietnam (12, 13). The second test is a locally available urine dipstick (Quickstick one-step hCG Pregnancy Test, Phamatech, San Diego, CA, USA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High sensitivity urine pregnancy test | Other | Standard medical care and high sensitivity urine pregnancy test |
|
| Semi-quantitative panel test | Other | Standard medical care and semi-quantitative panel test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semi-quantitative panel test | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of these two types of home pregnancy tests | Accuracy of these two types of home pregnancy tests to identify continuing pregnancy at four, seven and fourteen days after mifepristone administration. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the two types of pregnancy tests at identifying continuing pregnancy | 2 weeks | |
| The use and acceptability of the two tests | The use and acceptability of the two tests for women as a diagnostic tool to assess pregnancy status at home following early medical abortion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Nguyen Thi Nhu Ngoc, MD, MsC | CRCRH | Principal Investigator |
| Paul Blumenthal, MD | Stanford University | Principal Investigator |
| Wendy Sheldon, MPH, MSW, PhD | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hocmon General District Hospital | Hochiminh City | Vietnam | ||||
| Hungvuong Hospital |
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| High sensitivity urine pregnancy test |
| Device |
|
|
| 2 weeks |
| Correlation between the pregnancy test results determined by the woman at home and the abortion outcome determined by provider | 2 weeks |
| Hochiminh City |
| Vietnam |