Clinical trial NCT01150279: Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up
Official title: Simplifying Medical Abortion Provision: Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Abortion
Keywords: medical abortion
Medical Abortion Follow Up Care
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Secretaría de Salud del Distrito Federal
name: Office National de la Famille et de la Population, Tunisia
name: Maternité de la Rabta, Tunisia
name: Clinique du Parc, Tunisia
First posted: 2010-06-24
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women presenting to clinic seeking medical abortion

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. 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.


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

Primary outcomes:
measure: Percent of women who correctly interpreted their results (in U.S. and Vietnam only)
timeFrame: 18 months
Secondary outcomes:
measure: 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
timeFrame: 18 months
measure: The proportion of times the provider believes that each participant correctly read her test result
timeFrame: 18 months
measure: Percent of providers who were comfortable with the urine pregnancy test determining whether women need to return or not for clinic-based follow-up
timeFrame: 18 months
measure: The proportion of times that the semi-quantitative test correctly identifies all on going pregnancies
timeFrame: 18 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Hospital
state: California
city: Sacramento
country: United States
facility: Planned Parenthood Mar Monte
state: California
city: Chicago
country: United States
facility: Family Planning Associates Group - Washington
state: Illinois
city: Chicago
country: United States
facility: Family Planning Associates- Elston
state: Illinois
city: Mexico City
country: Mexico
facility: Hospital Materno Infantil Nicolas M. Cedillo
city: Ben Arous
country: Tunisia
facility: ONFP Ben Arous
city: Nabeul
country: Tunisia
facility: ONFP Nabeul
city: Sousse
country: Tunisia
facility: ONFP Sousse
city: Tunis
country: Tunisia
facility: Clinique du Parc
city: Tunis
country: Tunisia
facility: Maternite de la Rabta
city: Ho Chi Minh City
country: Vietnam
facility: HocMon District Hospital
Study officials:
affiliation: Stanford University
name: Paul D Blumenthal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Investigator
name: Jennifer Blum, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Secretaría de Salud del Distrito Federal
name: Patricio Sanhueza Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Office National de la Famille et de la Population
name: Rym Fayala, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maternité de la Rabta
name: Ezzedine Sfar
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique du Parc
name: Hella Chelli
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Rasha Dabash, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.