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

NCT01150279 | Completed

• 1 other identifier: 6.1.3
• Study Type: observational
• Target: 1,200
• Locations: 4 countries
• Sites: 11

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. 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. 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. 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.

Conditions

Medical Abortion

Keywords

medical abortion; Medical Abortion Follow Up Care

Outcome Measures

Primary Outcomes (1)

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

  18 months

Secondary Outcomes (4)

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women presenting to clinic seeking medical abortion

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.
• 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
• Women not eligible for medical abortion services
• Women unable to provide contact information
• Women unable to sign the consent form

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Stanford University: collaborator
• Secretaría de Salud del Distrito Federal: collaborator
• Office National de la Famille et de la Population, Tunisia: collaborator
• Maternité de la Rabta, Tunisia: collaborator
• Clinique du Parc, Tunisia: collaborator

Study Sites (11)

Stanford University Hospital

Palo Alto, California, United States

Location

Planned Parenthood Mar Monte

Sacramento, California, United States

Location

Family Planning Associates Group - Washington

Chicago, Illinois, United States

Location

Family Planning Associates- Elston

Chicago, Illinois, United States

Location

Hospital Materno Infantil Nicolas M. Cedillo

Mexico City, Mexico

Location

ONFP Ben Arous

Ben Arous, Tunisia

Location

ONFP Nabeul

Nabeul, Tunisia

Location

ONFP Sousse

Sousse, Tunisia

Location

Clinique du Parc

Tunis, Tunisia

Location

Maternite de la Rabta

Tunis, Tunisia

Location

HocMon District Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (2)

• 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.

  PMID: 27475998 DERIVED

• 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.

  PMID: 23477704 DERIVED

Study Officials

• Paul D Blumenthal, MD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Jennifer Blum, MPH

  Gynuity Health Investigator

  PRINCIPAL INVESTIGATOR

• Patricio Sanhueza Smith, MD

  Secretaría de Salud del Distrito Federal

  PRINCIPAL INVESTIGATOR

• Rym Fayala, MD

  Office National de la Famille et de la Population

  PRINCIPAL INVESTIGATOR

• Ezzedine Sfar

  Maternité de la Rabta

  PRINCIPAL INVESTIGATOR

• Hella Chelli

  Clinique du Parc

  PRINCIPAL INVESTIGATOR

• Rasha Dabash, MPH

  Gynuity Health Projects

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: June 24, 2010
• Study Start: August 1, 2009
• Primary Completion: May 1, 2014
• Last Updated: October 2, 2015

Record last verified: 2015-10

Locations

ME (1); US (4); VN (1); TU (5)