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Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine

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ClinicalTrials.gov Identifier: NCT02513043
Recruitment Status : Recruiting
First Posted : July 31, 2015
Last Update Posted : June 1, 2018
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 : 1000 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 2019
Estimated Study Completion Date : June 2019

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

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Ages Eligible for Study:   11 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, Hawaii
The University of Hawaii Women's Options Centers Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Mary Tschann, MPH    808-203-6561      
Principal Investigator: Bliss Kaneshiro, MD, MPH         
United States, Maine
Maine Family Planning Recruiting
Augusta, Maine, United States, 04332
Contact: Shannon Mackey    207-248-3924      
Principal Investigator: Leah Coplon, MPH, RN         
United States, New York
Choices Women's Medical Center Active, not recruiting
Jamaica, New York, United States, 11435
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: Ariela Schyner    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     History of Changes
Other Study ID Numbers: 1031
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018