Medical AbortionNCT01150279
Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up
An observational study of Medical Abortion, run by Gynuity Health Projects at 11 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Abortion
- How many people
- 1,200 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Aug 2009to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women presenting to clinic seeking medical abortion
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Tunisia5 sites
ONFP Ben Arous
Ben Arous
ONFP Nabeul
Nabeul
ONFP Sousse
Sousse
Clinique du Parc
Tunis
Maternite de la Rabta
Tunis
United States4 sites
Family Planning Associates Group - Washington
Chicago, Illinois
Family Planning Associates- Elston
Chicago, Illinois
Stanford University Hospital
Palo Alto, California
Planned Parenthood Mar Monte
Sacramento, California
About this study
Official title: Simplifying Medical Abortion Provision: Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up
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:
- 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 .
- To determine if women using this test at home understand how to use it and can correctly interpret the results; is it practical.
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of women who correctly interpreted their results (in U.S. and Vietnam only)
Measured: 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
Measured: 18 months
The proportion of times the provider believes that each participant correctly read her test result
Measured: 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
Measured: 18 months
The proportion of times that the semi-quantitative test correctly identifies all on going pregnancies
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startAug 2009
- Primary completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medical AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Paul D Blumenthal, MD, MPH, Principal investigator, Stanford UniversityBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsJennifer Blum, MPH, Principal investigator, Gynuity Health InvestigatorPatricio Sanhueza Smith, MD, Principal investigator, Secretaría de Salud del Distrito FederalRym Fayala, MD, Principal investigator, Office National de la Famille et de la PopulationEzzedine Sfar, Principal investigator, Maternité de la RabtaHella Chelli, Principal investigator, Clinique du ParcRasha Dabash, MPH, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150279
- Sponsor's protocol ID
- 6.1.3
- Status last verified
- Oct 2015
- First submitted
- 13 May 2010
- Last updated
- 2 Oct 2015
- Results posted
- No
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 27475998Lynd 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplifying Medical Abortion Provision: Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up
- ClinicalTrials.gov ID
- NCT01150279
- Acronym / sponsor ID
- 6.1.3
- Conditions
- Medical Abortion
- Keywords
- medical abortion, Medical Abortion Follow Up Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- 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
- Study start
- Aug 2009
- Primary completion
- May 2014 (actual)
- First posted
- 24 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 .
- To determine if women using this test at home understand how to use it and can correctly interpret the results; is it practical.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women presenting to clinic seeking medical abortion
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent of women who correctly interpreted their results (in U.S. and Vietnam only)
Time frame: 18 months
4 secondary outcomes
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
The proportion of times the provider believes that each participant correctly read her test result
Time frame: 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
Time frame: 18 months
The proportion of times that the semi-quantitative test correctly identifies all on going pregnancies
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
- Derived from this study: PubMed 27475998Dabash 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.
- Derived from this study: PubMed 23477704Lynd 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Abortion, run by Gynuity Health Projects at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Tunisia, United States, Mexico, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of women who correctly interpreted their results (in U.S. and Vietnam only) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01150279, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015.