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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

Tracking Information
First Submitted Date October 19, 2020
First Posted Date October 23, 2020
Last Update Posted Date February 4, 2022
Actual Study Start Date October 1, 2020
Actual Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 22, 2020)		 Number of participants with adverse events [ Time Frame: 2 years ]
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 Telemedicine Medical Abortion
Official Title TelAbortion: Medical Abortion by Direct-to-patient Telemedicine and Mail
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.
Detailed Description Not Provided
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 People seeking abortion
Condition Pregnancy
Intervention Drug: medical abortion
medical abortion
Study Groups/Cohorts Pregnant people
Intervention: Drug: medical abortion
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 Completed
Actual Enrollment
 (submitted: February 3, 2022)		 413
Original Estimated Enrollment
 (submitted: October 22, 2020)		 2500
Actual Study Completion Date October 1, 2021
Actual Primary Completion Date October 1, 2021   (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 Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04599725
Other Study ID Numbers 1049
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Current Responsible Party Gynuity Health Projects
Original Responsible Party Same as current
Current Study Sponsor Gynuity Health Projects
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Elizabeth Raymond, MD, MPH Gynuity Health Projects
PRS Account Gynuity Health Projects
Verification Date October 2020