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Completed

NCT Number: NCT01150279

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

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.

Completed

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Key information

Conditions

Medical Abortion

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Materno Infantil Nicolas M. Cedillo, Mexico City, Mexico

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 18 months

Secondary outcomes

  1. 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

    Time frame: 18 months

  2. The proportion of times the provider believes that each participant correctly read her test result

    Time frame: 18 months

  3. Percent of providers who were comfortable with the urine pregnancy test determining whether women need to return or not for clinic-based follow-up

    Time frame: 18 months

  4. The proportion of times that the semi-quantitative test correctly identifies all on going pregnancies

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Clinique du Parc, Tunisia
  • Maternité de la Rabta, Tunisia
  • Office National de la Famille et de la Population, Tunisia
  • Secretaría de Salud del Distrito Federal
  • Stanford University

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
First posted
Jun 24, 2010
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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