Status:

COMPLETED

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

Lead Sponsor:

Gynuity Health Projects

Collaborating Sponsors:

Stanford University

Secretaría de Salud del Distrito Federal

Conditions:

Medical Abortion

Eligibility:

FEMALE

18-55 years

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

1200 Patients enrolled

Trial Details

Trial ID

NCT01150279

Start Date

August 1 2009

Last Update

October 2 2015

Active Locations (11)

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Page 1 of 3 (11 locations)

1

Stanford University Hospital

Palo Alto, California, United States

2

Planned Parenthood Mar Monte

Sacramento, California, United States

3

Family Planning Associates Group - Washington

Chicago, Illinois, United States

4

Family Planning Associates- Elston

Chicago, Illinois, United States