Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up
This study is currently recruiting participants.
Verified March 2013 by Gynuity Health Projects
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
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01150279
First received: May 13, 2010
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
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 Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Simplifying Medical Abortion Provision: Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up |
Further study details as provided by Gynuity Health Projects:
Primary Outcome Measures:
- Percent of women who correctly interpreted their results [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- The proportion of times the provider believes that each participant correctly read her test result [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- The proportion of times that the semi-quantitative test correctly identifies all on going pregnancies [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | August 2009 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Women presenting to clinic seeking medical abortion
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01150279
Locations
| United States, California | |
| Stanford University Hospital | Completed |
| Palo Alto, California, United States | |
| Planned Parenthood Mar Monte | Completed |
| Sacramento, California, United States | |
| United States, Illinois | |
| Family Planning Associates Group - Washington | Completed |
| Chicago, Illinois, United States | |
| Family Planning Associates- Elston | Completed |
| Chicago, Illinois, United States | |
| Mexico | |
| Hospital Materno Infantil Nicolas M. Cedillo | Recruiting |
| Mexico City, Mexico | |
| Contact: Dolores C Constantino, MD 5553676-0615 cocdvam@hotmail.com | |
| Tunisia | |
| ONFP Ben Arous | Recruiting |
| Ben Arous, Tunisia | |
| Contact: Rym Fayala, MD rymfayala@gmail.com | |
| ONFP Nabeul | Recruiting |
| Nabeul, Tunisia | |
| Contact: Rym Fayala rymfayala@gmail.com | |
| ONFP Sousse | Recruiting |
| Sousse, Tunisia | |
| Contact: Rym Fayala, MD rymfayala@gmail.com | |
| Maternite de la Rabta | Recruiting |
| Tunis, Tunisia | |
| Contact: Ezzedine Sfar ezzedine.sfar@rns.tn | |
| Clinique du Parc | Recruiting |
| Tunis, Tunisia | |
| Contact: Hela Chelli hela.chelli@laposte.net | |
| Vietnam | |
| HocMon District Hospital | Completed |
| Ho Chi Minh City, Vietnam | |
Sponsors and Collaborators
Gynuity Health Projects
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
Investigators
| Principal Investigator: | 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 |
| Study Director: | Rasha Dabash, MPH | Gynuity Health Projects |
More Information
No publications provided
| Responsible Party: | Gynuity Health Projects |
| ClinicalTrials.gov Identifier: | NCT01150279 History of Changes |
| Other Study ID Numbers: | 6.1.3 |
| Study First Received: | May 13, 2010 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Institutional Review Board Mexico: Secretary of Health of Mexico Tunisia: La Rabta Maternity Hospital's Research Ethics Committee |
Keywords provided by Gynuity Health Projects:
|
medical abortion Medical Abortion Follow Up Care |
ClinicalTrials.gov processed this record on May 16, 2013