Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up
NCT ID: NCT01150279
Last Updated: 2015-10-02
Study Results
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Basic Information
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COMPLETED
1200 participants
OBSERVATIONAL
2009-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
55 Years
FEMALE
Yes
Sponsors
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Stanford University
OTHER
Secretaría de Salud del Distrito Federal
UNKNOWN
Office National de la Famille et de la Population, Tunisia
UNKNOWN
Maternité de la Rabta, Tunisia
UNKNOWN
Clinique du Parc, Tunisia
UNKNOWN
Gynuity Health Projects
OTHER
Responsible Party
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Principal Investigators
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Paul D Blumenthal, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Beverly Winikoff, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Jennifer Blum, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Investigator
Patricio Sanhueza Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Secretaría de Salud del Distrito Federal
Rym Fayala, MD
Role: PRINCIPAL_INVESTIGATOR
Office National de la Famille et de la Population
Ezzedine Sfar
Role: PRINCIPAL_INVESTIGATOR
Maternité de la Rabta
Hella Chelli
Role: PRINCIPAL_INVESTIGATOR
Clinique du Parc
Rasha Dabash, MPH
Role: STUDY_DIRECTOR
Gynuity Health Projects
Locations
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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
Countries
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References
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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.
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.
Other Identifiers
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6.1.3
Identifier Type: -
Identifier Source: org_study_id
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