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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02513043
Recruitment Status : Completed
First Posted : July 31, 2015
Last Update Posted : February 4, 2022
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Study Description
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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.
Study Design
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Study Type : Observational
Actual Enrollment : 1470 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
Actual Primary Completion Date : May 11, 2021
Actual Study Completion Date : May 11, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abortion Telehealth

Groups and Cohorts
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Intervention Details:
  • Drug: medical abortion
    medical abortion

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


Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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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
Denver, Colorado, United States, 80207
United States, District of Columbia
Carafem
Washington, District of Columbia, United States, 20815
United States, Georgia
Carafem
Atlanta, Georgia, United States, 30309
United States, Hawaii
The University of Hawaii Women's Options Centers
Honolulu, Hawaii, United States, 96826
United States, Illinois
Carafem
Skokie, Illinois, United States, 60076
United States, Iowa
Emma Goldman Clinic
Iowa City, Iowa, United States, 52245
United States, Maine
Maine Family Planning
Augusta, Maine, United States, 04332
United States, Maryland
Carafem
Chevy Chase, Maryland, United States, 20815
United States, Minnesota
Planned Parenthood Minnesota, North Dakota, South Dakota
Saint Paul, Minnesota, United States, 55114
United States, Montana
Planned Parenthood of Montana
Billings, Montana, United States, 59102
United States, New Mexico
Planned Parenthood of the Rocky Mountains
New Mexico, New Mexico, United States, 80207
United States, New York
Choices Women's Medical Center
Jamaica, New York, United States, 11435
Maine Family Planning
New York, New York, United States, 04332
United States, Oregon
Planned Parenthood Columbia Willamette
Portland, Oregon, United States, 97212
Oregon Health and Sciences University Women's Health Research Unit
Portland, Oregon, United States, 97239
United States, Washington
Planned Parenthood Columbia Willamette
Washington, Washington, United States, 97212
Oregon Health and Sciences University Women's Health Research Unit
Washington, Washington, United States, 97239
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
More Information
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Layout table for additonal information
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: February 4, 2022
Last Verified: July 2020