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

Completed

Conditions studied: Medical Abortion

In brief

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.

Key facts

Study ID

NCT01150279

Run by

Gynuity Health Projects

People needed

1200

Starts

2009-08-01

Last updated by the study team

2015-10-02

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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