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Clinical Trials/NCT01150279
NCT01150279CompletedNot Applicable

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

Gynuity Health Projects11 sites in 4 countries1,200 target enrollmentStarted: August 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,200
Locations
11
Primary Endpoint
Percent of women who correctly interpreted their results (in U.S. and Vietnam only)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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:

  1. 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 .
  2. To determine if women using this test at home understand how to use it and can correctly interpret the results; is it practical.
  3. 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Percent of women who correctly interpreted their results (in U.S. and Vietnam only)

Time Frame: 18 months

Secondary Outcomes

  • 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)
  • 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)

Investigators

Sponsor
Gynuity Health Projects
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (11)

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