Medical Abortion
Conditions
Keywords
Medical Abortion, Pregnancy Test, continuing pregnancy
Brief summary
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). 1. The investigators hypothesize that 99% of the SQPT and 35% of the HSPT will correctly identify ongoing pregnancy at day 14. 2. The investigators hypothesize that 99% of the SQPT and 25% of the HSPT will correctly identify ongoing pregnancy at day 7. 3. The investigators hypothesize that 75% of the SQPT and 10% of the HSPT will correctly identify ongoing pregnancy at day 4.
Interventions
DEVICESemi-quantitative panel test
DEVICEHigh sensitivity urine pregnancy test
Sponsors
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Gestational age ≤63days from LMP * Eligible for mifepristone- misoprostol medical abortion according to clinic guidelines(national guidelines stipulate that women can receive medical abortion thru 63 days LMP at Hung Vuong (tertiary level) hospital; women with gestations up to 49 days LMP can receive medical abortion at Hocmon (district) hospital) * Willing to follow instructions of the provider regarding use of the pregnancy tests * Able to read and write to use pregnancy test at home * Willing to be randomized to perform one of two types of urine pregnancy tests at three time points at home * Willing to provide an address and/or telephone number for purposes of follow-up * Agrees to return for follow-up visit at clinic to confirm abortion status * Wishes to participate in the study * Able to consent to study participation
Exclusion criteria
* Women not meeting the above inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of these two types of home pregnancy tests | 2 weeks | Accuracy of these two types of home pregnancy tests to identify continuing pregnancy at four, seven and fourteen days after mifepristone administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the two types of pregnancy tests at identifying continuing pregnancy | 2 weeks | — |
| The use and acceptability of the two tests | 2 weeks | The use and acceptability of the two tests for women as a diagnostic tool to assess pregnancy status at home following early medical abortion |
| Correlation between the pregnancy test results determined by the woman at home and the abortion outcome determined by provider | 2 weeks | — |
Countries
Vietnam
Outcome results
None listed