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Feasibility of Telemedicine Medical Abortion

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: NCT04599725
Recruitment Status : Completed
First Posted : October 23, 2020
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 data on the safety, acceptability, and feasibility of providing abortion by direct-to-patient telemedicine and mail.

Condition or disease Intervention/treatment
Pregnancy Drug: medical abortion

Study Design
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Study Type : Observational
Actual Enrollment : 413 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: TelAbortion: Medical Abortion by Direct-to-patient Telemedicine and Mail
Actual Study Start Date : October 1, 2020
Actual Primary Completion Date : October 1, 2021
Actual Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abortion Telehealth

Groups and Cohorts
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Group/Cohort Intervention/treatment
Pregnant people Drug: medical abortion
medical abortion


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 2 years ]

Eligibility Criteria
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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
People 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): NCT04599725


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, Massachusetts
Maine Family Planning
Boston, Massachusetts, United States, 02134
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
Albuquerque, New Mexico, United States, 80207
United States, New York
Maine Family Planning
New York, New York, United States, 04332
United States, Oregon
Planned Parenthood Columbia Willamette
Portland, Oregon, United States, 97212
United States, Washington
Planned Parenthood Columbia Willamette
Vancouver, Washington, United States, 97212
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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Principal Investigator: Elizabeth Raymond, MD, MPH Gynuity Health Projects
More Information
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT04599725    
Other Study ID Numbers: 1049
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: February 4, 2022
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes