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

This study is currently recruiting participants.
Verified February 2014 by Gynuity Health Projects
Sponsor:
Collaborators:
Stanford University
Secretaría de Salud del Distrito Federal
Office National de la Famille et de la Population, Tunisia
Maternité de la Rabta, Tunisia
Clinique du Parc, Tunisia
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01150279
First received: May 13, 2010
Last updated: February 18, 2014
Last verified: February 2014

May 13, 2010
February 18, 2014
August 2009
March 2014   (final data collection date for primary outcome measure)
Percent of women who correctly interpreted their results [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01150279 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • The proportion of times the provider believes that each participant correctly read her test result [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The proportion of times that the semi-quantitative test correctly identifies all on going pregnancies [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up
Simplifying Medical Abortion Provision: 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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Women presenting to clinic seeking medical abortion

Medical Abortion
Not Provided
Not Provided
Lynd K, Blum J, Ngoc NT, Shochet T, Blumenthal PD, Winikoff B. Simplified medical abortion using a semi-quantitative pregnancy test for home-based follow-up. Int J Gynaecol Obstet. 2013 May;121(2):144-8. doi: 10.1016/j.ijgo.2012.11.022. Epub 2013 Mar 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
Not Provided
March 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 55 Years
Yes
Not Provided
United States,   Mexico,   Tunisia,   Vietnam
 
NCT01150279
6.1.3
Not Provided
Gynuity Health Projects
Gynuity Health Projects
  • Stanford University
  • Secretaría de Salud del Distrito Federal
  • Office National de la Famille et de la Population, Tunisia
  • Maternité de la Rabta, Tunisia
  • Clinique du Parc, Tunisia
Principal Investigator: Paul D Blumenthal, MD, MPH Stanford University
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Principal Investigator: Jennifer Blum, MPH Gynuity Health Investigator
Principal Investigator: Patricio Sanhueza Smith, MD Secretaría de Salud del Distrito Federal
Principal Investigator: Rym Fayala, MD Office National de la Famille et de la Population
Principal Investigator: Ezzedine Sfar Maternité de la Rabta
Principal Investigator: Hella Chelli Clinique du Parc
Study Director: Rasha Dabash, MPH Gynuity Health Projects
Gynuity Health Projects
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP