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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.

Condition Phase
Medical Abortion
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Simplifying Medical Abortion Provision: Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Percent of women who correctly interpreted their results [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1200
Study Start Date: August 2009
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Women presenting to clinic seeking medical abortion

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150279

Locations
United States, California
Stanford University Hospital Completed
Palo Alto, California, United States
Planned Parenthood Mar Monte Completed
Sacramento, California, United States
United States, Illinois
Family Planning Associates Group - Washington Completed
Chicago, Illinois, United States
Family Planning Associates- Elston Completed
Chicago, Illinois, United States
Mexico
Hospital Materno Infantil Nicolas M. Cedillo Recruiting
Mexico City, Mexico
Contact: Dolores C Constantino, MD    5553676-0615    cocdvam@hotmail.com   
Tunisia
ONFP Ben Arous Recruiting
Ben Arous, Tunisia
Contact: Rym Fayala, MD       rymfayala@gmail.com   
ONFP Nabeul Recruiting
Nabeul, Tunisia
Contact: Rym Fayala       rymfayala@gmail.com   
ONFP Sousse Recruiting
Sousse, Tunisia
Contact: Rym Fayala, MD       rymfayala@gmail.com   
Clinique du Parc Recruiting
Tunis, Tunisia
Contact: Hela Chelli       hela.chelli@laposte.net   
Maternite de la Rabta Recruiting
Tunis, Tunisia
Contact: Ezzedine Sfar       ezzedine.sfar@rns.tn   
Vietnam
HocMon District Hospital Completed
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
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
Investigators
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
  More Information

No publications provided by Gynuity Health Projects

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01150279     History of Changes
Other Study ID Numbers: 6.1.3
Study First Received: May 13, 2010
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board
Mexico: Secretary of Health of Mexico
Tunisia: La Rabta Maternity Hospital's Research Ethics Committee

Keywords provided by Gynuity Health Projects:
medical abortion
Medical Abortion Follow Up Care

ClinicalTrials.gov processed this record on November 24, 2014