Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up

Study Overview
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Brief Summary
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This study will examine the feasibility, acceptability and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) for at-home follow-up after early medical abortion using mifepristone+misoprostol. The study seeks to: Assess the feasibility of using this test in lieu of standard one-week clinic-based follow up for determination of complete abortion status as part of normal service delivery. In Mexico, follow up will be in two weeks, as is standard care in that . To determine if women using this test at home understand how to use it and can correctly interpret the results; is it practical. Assess women's and provider's acceptability of using at-home pregnancy tests in lieu of clinic-based follow up for confirmation of complete medical abortion in the future.

Official Title
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Simplifying Medical Abortion Provision: Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up

Conditions
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Medical Abortion

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women age greater than or equal to 18 years Gestational age less than or equal to 63 days by last menstrual period (LMP), ultrasound or clinical assessment Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up Able to consent to study participation. Inclusion Criteria for Mexico: Gestational age <_ 70 days from LMP Eligible for mifepristone- misoprostol medical abortion according to clinic guidelines Willing to follow instructions of the provider regarding use of the at-home pregnancy test Agrees to provide test results by phone to study coordinator on morning of schedule follow-up visit Willing to provide an address and/or telephone number for purposes of follow-up Agrees to return for standard follow-up visit Wishes to participate in the study Having easy access to a telephone and transportation Able to consent to study participation Exclusion Criteria: Women less than 18 years of age Women not eligible for medical abortion services Women unable to provide contact information Women unable to sign the consent form Exclusion Criteria for Mexico: Women not eligible for medical abortion services Women unable to provide contact information Women unable to sign the consent form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of women who correctly interpreted their results (in U.S. and Vietnam only) |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of women who felt confident in using the test and would be willing to use it in place of clinic-based follow up in the future |  | 18 months | 
| The proportion of times the provider believes that each participant correctly read her test result |  | 18 months | 
| Percent of providers who were comfortable with the urine pregnancy test determining whether women need to return or not for clinic-based follow-up |  | 18 months | 
| The proportion of times that the semi-quantitative test correctly identifies all on going pregnancies |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical abortion, Medical Abortion Follow Up Care