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Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02513043
Recruitment Status : Recruiting
First Posted : July 31, 2015
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
This pilot study is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.

Condition or disease Intervention/treatment
Pregnancy Drug: medical abortion

Detailed Description:
The objective of this pilot study is to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine
Study Start Date : March 22, 2016
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Intervention Details:
  • Drug: medical abortion
    medical abortion


Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ]
    adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women seeking abortion
Criteria

Inclusion Criteria:

  • desires abortion

Exclusion Criteria:

  • medically ineligible for procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513043


Locations
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United States, Colorado
Planned Parenthood of the Rocky Mountains Recruiting
Denver, Colorado, United States, 80207
Contact: Kristina Tocce, MD    303-813-7762      
Principal Investigator: Kristina Tocce, MD         
United States, District of Columbia
Carafem Recruiting
Washington, District of Columbia, United States, 20815
Contact: Lisa Schulter    877-721-2596      
Principal Investigator: Susan Haskell         
United States, Georgia
Carafem Recruiting
Atlanta, Georgia, United States, 30309
Contact: Lisa Schulter    877-721-2596      
Principal Investigator: Susan Haskell, DO         
United States, Hawaii
The University of Hawaii Women's Options Centers Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Jasmine Tyson, MS    888-971-7137      
Principal Investigator: Bliss Kaneshiro, MD, MPH         
United States, Illinois
Carafem Recruiting
Skokie, Illinois, United States, 60076
Contact: Lisa Schulter    877-721-2596      
Principal Investigator: Susan Haskell, DO         
United States, Iowa
Emma Goldman Clinic Recruiting
Iowa City, Iowa, United States, 52245
Contact: Abbey Hardy - Fairbanks, MD, FACOG    319-337-2112      
Principal Investigator: Abbey Hardy - Fairbanks         
United States, Maine
Maine Family Planning Recruiting
Augusta, Maine, United States, 04332
Contact: Nicole Mathieu    207-626-3243      
Principal Investigator: Leah Coplon, MPH, RN         
United States, Maryland
Carafem Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Lisa Schulter    877-721-2596      
Principal Investigator: Susan Haskell, DO         
United States, Minnesota
Planned Parenthood Minnesota, North Dakota, South Dakota Recruiting
Saint Paul, Minnesota, United States, 55114
Contact: Shay Gingras    612-821-6141      
Principal Investigator: Christy M Boraas, M.D., MPH         
United States, Montana
Planned Parenthood of Montana Not yet recruiting
Billings, Montana, United States, 59102
Contact: Ali Kelly    406-869-5000      
Principal Investigator: Joey Banks, MD         
United States, New Mexico
Planned Parenthood of the Rocky Mountains Recruiting
New Mexico, New Mexico, United States, 80207
Contact: Kristina Tocce, MD    303.813.7762      
Principal Investigator: Kristina Tocce, MD         
United States, New York
Choices Women's Medical Center Active, not recruiting
Jamaica, New York, United States, 11435
Maine Family Planning Recruiting
New York, New York, United States, 04332
Contact: Nicole Mathieu    207-626-3243      
Principal Investigator: Leah Coplon, MPH, RN         
United States, Oregon
Planned Parenthood Columbia Willamette Recruiting
Portland, Oregon, United States, 97212
Contact: Meghan Keady    503-775-4931 ext 3144      
Principal Investigator: Paula Bednarek, MD, MPH         
Oregon Health and Sciences University Women's Health Research Unit Recruiting
Portland, Oregon, United States, 97239
Contact: Oluwadamilola Sosanya    503-494-3959      
Principal Investigator: Maureen Baldwin, MD         
United States, Washington
Planned Parenthood Columbia Willamette Recruiting
Washington, Washington, United States, 97212
Contact: Meghan Keady    503-775-4931 ext 3144      
Principal Investigator: Paula Bednarek, MD, MPH         
Oregon Health and Sciences University Women's Health Research Unit Recruiting
Washington, Washington, United States, 97239
Contact: Oluwadamilola Sosanya    503-494-3959      
Principal Investigator: Maureen Baldwin, MD         
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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Principal Investigator: Erica Chong, MPH Gynuity Health Projects
Principal Investigator: Elizabeth Raymond, MD, MPH Gynuity Health Projects
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02513043    
Other Study ID Numbers: 1031
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020