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CompletedNCT01150279Updated Oct 2, 2015

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

An observational study in Medical Abortion, sponsored by Gynuity Health Projects. Completed at 11 sites in 4 countries. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-02.

Sponsored by Gynuity Health Projects · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,200
Ages
18 Years to 55 Years
Sex
Female
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Study 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.
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Conditions studied

  • Medical Abortion

Keywords

  • medical abortion
  • Medical Abortion Follow Up Care
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In context

Lead sponsor

Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Women presenting to clinic seeking medical abortion

Eligibility criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,200 participants (actual)
06

What researchers measure

Primary outcomes

  1. Percent of women who correctly interpreted their results (in U.S. and Vietnam only)

    Time frame: 18 months

Secondary outcomes

  1. 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

    Time frame: 18 months

  2. The proportion of times the provider believes that each participant correctly read her test result

    Time frame: 18 months

  3. Percent of providers who were comfortable with the urine pregnancy test determining whether women need to return or not for clinic-based follow-up

    Time frame: 18 months

  4. The proportion of times that the semi-quantitative test correctly identifies all on going pregnancies

    Time frame: 18 months

07

Study locations

11 sites
  • 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
08

References and documents

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. PubMed 27475998 ↗
  • 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. PubMed 23477704 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01150279
Lead 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
Responsible party
Sponsor
First posted
Jun 24, 2010
Start date
Aug 2009
Primary completion
May 2014
Last update
Oct 2, 2015

Study contacts

Paul D Blumenthal, MD, MPH
principal investigator · Stanford University
Beverly Winikoff, MD, MPH
principal investigator · Gynuity Health Projects
Jennifer Blum, MPH
principal investigator · Gynuity Health Investigator
Patricio Sanhueza Smith, MD
principal investigator · Secretaría de Salud del Distrito Federal
Rym Fayala, MD
principal investigator · Office National de la Famille et de la Population
Ezzedine Sfar
principal investigator · Maternité de la Rabta
Hella Chelli
principal investigator · Clinique du Parc
Rasha Dabash, MPH
study director · Gynuity Health Projects
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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