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.

Study Overview

• Status: Completed
• Conditions: Medical Abortion

• Study Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Hospital Materno Infantil Nicolas M. Cedillo
• Tunisia
  • Ben Arous, Tunisia
    • ONFP Ben Arous
  • Nabeul, Tunisia
    • ONFP Nabeul
  • Sousse, Tunisia
    • ONFP Sousse
  • Tunis, Tunisia
    • Clinique du parc
  • Tunis, Tunisia
    • Maternité de La Rabta
• United States
  • California
    • Palo Alto, California, United States
      • Stanford University Hospital
    • Sacramento, California, United States
      • Planned Parenthood Mar Monte
  • Illinois
    • Chicago, Illinois, United States
      • Family Planning Associates Group - Washington
    • Chicago, Illinois, United States
      • Family Planning Associates- Elston
• Vietnam
  • Ho Chi Minh City, Vietnam
    • HocMon District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women presenting to clinic seeking medical abortion

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• 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
• Investigators: 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

Publications and helpful links

General Publications

• Dabash R, Shochet T, Hajri S, Chelli H, Hassairi AE, Haleb D, Labassi H, Sfar E, Temimi F, Koenig L, Winikoff B. Self-administered multi-level pregnancy tests in simplified follow-up of medical abortion in Tunisia. BMC Womens Health. 2016 Jul 30;16:49. doi: 10.1186/s12905-016-0327-1.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): May 1, 2014
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: May 13, 2010
• First Submitted That Met QC Criteria: June 23, 2010
• First Posted (Estimate): June 24, 2010

Study Record Updates

• Last Update Posted (Estimate): October 2, 2015
• Last Update Submitted That Met QC Criteria: October 1, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: medical abortion; Medical Abortion Follow Up Care
• Other Study ID Numbers: 6.1.3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No