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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 : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Tracking Information
First Submitted Date July 24, 2015
First Posted Date July 31, 2015
Last Update Posted Date August 3, 2020
Study Start Date March 22, 2016
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 30, 2015)
Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ]
adverse events
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine
Official Title Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women seeking abortion
Condition Pregnancy
Intervention Drug: medical abortion
medical abortion
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 30, 2020)
2500
Original Estimated Enrollment
 (submitted: July 30, 2015)
50
Estimated Study Completion Date June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • desires abortion

Exclusion Criteria:

  • medically ineligible for procedure
Sex/Gender
Sexes Eligible for Study: Female
Ages 10 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02513043
Other Study ID Numbers 1031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gynuity Health Projects
Study Sponsor Gynuity Health Projects
Collaborators Not Provided
Investigators
Principal Investigator: Erica Chong, MPH Gynuity Health Projects
Principal Investigator: Elizabeth Raymond, MD, MPH Gynuity Health Projects
PRS Account Gynuity Health Projects
Verification Date July 2020