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

Completed

• Conditions: Medical Abortion

• Registration Number: NCT01150279
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-06-23
• Study First Posted: 2010-06-24
• Primary Completion: 2014-05
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (11)

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

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