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

Gynuity Health Projects

Status: Completed

Conditions: Medical Abortion

Study type: Observational

Funder types: Other

Identifiers

NCT01150279

6.1.3

Details and patient eligibility

About

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.

Enrollment: 1,200 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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