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History of Changes for Study: NCT02513043
Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine
Latest version (submitted February 3, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 30, 2015 None (earliest Version on record)
2 August 4, 2015 Study Design and Study Status
3 March 8, 2016 Study Status
4 August 5, 2016 Recruitment Status, Study Status, Contacts/Locations and Oversight
5 May 10, 2017 Study Status, Contacts/Locations and Study Design
6 October 27, 2017 Study Status and Contacts/Locations
7 May 22, 2018 Study Status and Contacts/Locations
8 May 31, 2018 Contacts/Locations and Study Status
9 April 2, 2019 Study Status, Contacts/Locations and Eligibility
10 July 30, 2020 Study Status, Contacts/Locations and Study Design
11 February 3, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Changes (Merged) for Study: NCT02513043
April 2, 2019 (v9) -- July 30, 2020 (v10)

Changes in: Study Status, Study Design and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: 1031
Brief Title: Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine
Official Title: Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2019 July 2020
Overall Status: Recruiting
Study Start: March 22, 2016
Primary Completion: June 2020 2022 [Anticipated]
Study Completion: June 2020 2022 [Anticipated]
First Submitted: July 24, 2015
First Submitted that
Met QC Criteria:
July 30, 2015
First Posted: July 31, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 2, 2019 July 30, 2020
Last Update Posted: April 4 August 3, 2019 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Gynuity Health Projects
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This pilot study is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine 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.
Open or close this module Conditions
Conditions: Pregnancy
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Only
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 1000 2500 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Intervention Details:
Drug: medical abortion
medical abortion
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of participants with adverse events as a measure of safety and tolerability
[ Time Frame: 1 year ]

adverse events
Open or close this module Eligibility
Study Population: Women seeking abortion
Sampling Method: Non-Probability Sample
Minimum Age: 10 Years
Maximum Age: 50 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • desires abortion

Exclusion Criteria:

  • medically ineligible for procedure
Open or close this module Contacts/Locations
Study Officials: Erica Chong, MPH
Principal Investigator
Gynuity Health Projects
Elizabeth Raymond, MD, MPH
Principal Investigator
Gynuity Health Projects
Locations: United States, Colorado
Planned Parenthood of the Rocky Mountains
[Recruiting]
Denver, Colorado, United States, 80207
Contact:Contact: Kristina Tocce, MD 303-813-7762
Contact:Principal Investigator: Kristina Tocce, MD
United States, District of Columbia
Carafem
[Recruiting]
Washington, District of Columbia, United States, 20815
Contact:Contact: Lisa Schulter 877-721-2596
Contact:Principal Investigator: Susan Haskell
United States, Georgia
Carafem
[Recruiting]
Atlanta, Georgia, United States, 30309
Contact:Contact: Lisa Schulter 877-721-2596
Contact:Principal Investigator: Melissa Grant Susan Haskell, DO
United States, Hawaii
The University of Hawaii Women's Options Centers
[Recruiting]
Honolulu, Hawaii, United States, 96826
Contact:Contact: Tiana M Fontanilla Jasmine Tyson, MPH MS 888-971-7137
Contact:Principal Investigator: Bliss Kaneshiro, MD, MPH
United States, Illinois
Carafem
[Recruiting]
Skokie, Illinois, United States, 60076
Contact:Contact: Lisa Schulter 877-721-2596
Contact:Principal Investigator: Susan Haskell, DO
United States, Iowa
Emma Goldman Clinic
[Recruiting]
Iowa City, Iowa, United States, 52245
Contact:Contact: Abbey Hardy - Fairbanks, MD, FACOG 319-337-2112
Contact:Principal Investigator: Abbey Hardy - Fairbanks
United States, Maine
Maine Family Planning
[Recruiting]
Augusta, Maine, United States, 04332
Contact:Contact: Nicole Mathieu 207-626-3243
Contact:Principal Investigator: Leah Coplon, MPH, RN
United States, Maryland
Carafem
[Recruiting]
Chevy Chase, Maryland, United States, 20815
Contact:Contact: Lisa Schulter 877-721-2596
Contact:Principal Investigator: Susan Haskell, DO
United States, Minnesota
Planned Parenthood Minnesota, North Dakota, South Dakota
[Recruiting]
Saint Paul, Minnesota, United States, 55114
Contact:Contact: Shay Gingras 612-821-6141
Contact:Principal Investigator: Christy M Boraas, M.D., MPH
United States, Montana
Planned Parenthood of Montana
[Not yet recruiting]
Billings, Montana, United States, 59102
Contact:Contact: Ali Kelly 406-869-5000
Contact:Principal Investigator: Joey Banks, MD
United States, New Mexico
Planned Parenthood of the Rocky Mountains
[Recruiting]
New Mexico, New Mexico, United States, 80207
Contact:Contact: Kristina Tocce, MD 303.813.7762
Contact: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:Contact: Nicole Mathieu 207-626-3243
Contact:Principal Investigator: Leah Coplon, MPH, RN
United States, Oregon
Planned Parenthood Columbia Willamette
[Recruiting]
Portland, Oregon, United States, 97212
Contact:Contact: Meghan Keady 503-775-4931 Ext. 3144
Contact:Principal Investigator: Paula Bednarek, MD, MPH
Oregon Health and Sciences University Women's Health Research Unit
[Recruiting]
Portland, Oregon, United States, 97239
Contact:Contact: Ariela Schyner Oluwadamilola Sosanya 503-494-3959
Contact:Principal Investigator: Maureen Baldwin, MD
United States, Washington
Planned Parenthood Columbia Willamette
[Recruiting]
Washington, Washington, United States, 97212
Contact:Contact: Meghan Keady 503-775-4931 Ext. 3144
Contact:Principal Investigator: Paula Bednarek, MD, MPH
Oregon Health and Sciences University Women's Health Research Unit
[Recruiting]
Washington, Washington, United States, 97239
Contact:Contact: Ariela Schyner Oluwadamilola Sosanya 503-494-3959
Contact:Principal Investigator: Maureen Baldwin, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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