Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy

Study Overview
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Brief Summary
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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). The investigators hypothesize that 99% of the SQPT and 35% of the HSPT will correctly identify ongoing pregnancy at day 14. The investigators hypothesize that 99% of the SQPT and 25% of the HSPT will correctly identify ongoing pregnancy at day 7. The investigators hypothesize that 75% of the SQPT and 10% of the HSPT will correctly identify ongoing pregnancy at day 4.

Official Title
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Evaluating the Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy After Early Medical Abortion

Conditions
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Medical Abortion

Intervention / Treatment
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* Device: Semi-quantitative panel test
* Device: High sensitivity urine pregnancy test


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High sensitivity urine pregnancy test<br>Standard medical care and high sensitivity urine pregnancy test | Device: High sensitivity urine pregnancy test<br> <br> * Other names: Quickstick one-step hCG Pregnancy Test, Phamatech, San Diego, CA, USA;|
| Other: Semi-quantitative panel test<br>Standard medical care and semi-quantitative panel test | Device: Semi-quantitative panel test<br> <br> * Other names: dBest (AmeriTek, Seattle WA, USA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 2 weeks | 
| Correlation between the pregnancy test results determined by the woman at home and the abortion outcome determined by provider |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical Abortion, Pregnancy Test, continuing pregnancy