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History of Changes for Study: NCT02513043
Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine
Latest version (submitted April 2, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 30, 2015 Nothing (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
Comparison Format:

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Changes (Side-by-Side) for Study: NCT02513043
July 30, 2015 (v1) -- April 2, 2019 (v9)

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

Study Identification
Unique Protocol ID: 1031 1031
Brief Title: Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine
Official Title: Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine
Secondary IDs:
Study Status
Record Verification: July 2015 April 2019
Overall Status: Not yet recruiting Recruiting
Study Start: September 2015 March 22, 2016
Primary Completion: December 2016 [Anticipated ] June 2020 [Anticipated ]
Study Completion: December 2016 [Anticipated ] June 2020 [Anticipated ]
First Submitted: July 24, 2015 July 24, 2015
First Submitted that
Met QC Criteria:
July 30, 2015 July 30, 2015
First Posted: July 31, 2015 [Estimate ] July 31, 2015 [Estimate ]
Last Update Submitted that
Met QC Criteria:
July 30, 2015 April 2, 2019
Last Update Posted: July 31, 2015 [Estimate ] April 4, 2019 [Actual ]
Sponsor/Collaborators
Sponsor: Gynuity Health Projects Gynuity Health Projects
Responsible Party: Sponsor Sponsor
Collaborators:
Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No No
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. 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. The objective of this pilot study is to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.
Conditions
Conditions: Pregnancy Pregnancy
Keywords:
Study Design
Study Type: ObservationalObservational
Observational Study Model: Cohort Case-Only
Time Perspective: Prospective Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 50 [Anticipated ] 1000 [Anticipated ]
Number of Groups/Cohorts 00
Groups and Interventions
Intervention Details:
Drug : medical abortion
medical abortion
Drug : medical abortion
medical abortion
Outcome Measures
Primary Outcome Measures:
1. Number of participants with adverse events as a measure of safety and tolerability
adverse events

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

[Time Frame: 1 year ]
Eligibility
Study Population: Women seeking abortion Women seeking abortion
Sampling Method: Non-Probability Sample Non-Probability Sample
Minimum Age: 11 Years 10 Years
Maximum Age: 50 Years 50 Years
Sex: Female Female
Gender Based:
Accepts Healthy Volunteers: YesYes
Criteria:

Inclusion Criteria:

  • desires abortion

Exclusion Criteria:

  • medically ineligible for procedure

Inclusion Criteria:

  • desires abortion

Exclusion Criteria:

  • medically ineligible for procedure
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: Kristina Tocce, MD 303-813-7762
Principal Investigator: Kristina Tocce, MD
United States, Georgia
Carafem
[Recruiting]
Atlanta, Georgia, United States, 30309
Contact: Lisa Schulter 877-721-2596
Principal Investigator: Melissa Grant
United States, Hawaii
The University of Hawaii Women's Options Centers
[Recruiting]
Honolulu, Hawaii, United States, 96826
Contact: Tiana M Fontanilla, MPH 888-971-7137
Principal Investigator: Bliss Kaneshiro, MD, MPH
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, 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: Ariela Schyner 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: Ariela Schyner 503-494-3959
Principal Investigator: Maureen Baldwin, MD
IPDSharing
Plan to Share IPD:
References
Citations:
Links:
Available IPD/Information:

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