NCT04599725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
413

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 4, 2022

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

October 19, 2020

Last Update Submit

February 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    2 years

Study Arms (1)

Pregnant people

Drug: medical abortion

Interventions

medical abortion

Pregnant people

Eligibility Criteria

Age10 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

People seeking abortion

You may qualify if:

  • desires abortion

You may not qualify if:

  • medically ineligible for procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Planned Parenthood of the Rocky Mountains

Denver, Colorado, 80207, United States

Location

Carafem

Washington D.C., District of Columbia, 20815, United States

Location

Carafem

Atlanta, Georgia, 30309, United States

Location

The University of Hawaii Women's Options Centers

Honolulu, Hawaii, 96826, United States

Location

Carafem

Skokie, Illinois, 60076, United States

Location

Emma Goldman Clinic

Iowa City, Iowa, 52245, United States

Location

Maine Family Planning

Augusta, Maine, 04332, United States

Location

Carafem

Chevy Chase, Maryland, 20815, United States

Location

Maine Family Planning

Boston, Massachusetts, 02134, United States

Location

Planned Parenthood Minnesota, North Dakota, South Dakota

Saint Paul, Minnesota, 55114, United States

Location

Planned Parenthood of Montana

Billings, Montana, 59102, United States

Location

Planned Parenthood of the Rocky Mountains

Albuquerque, New Mexico, 80207, United States

Location

Maine Family Planning

New York, New York, 04332, United States

Location

Planned Parenthood Columbia Willamette

Portland, Oregon, 97212, United States

Location

Planned Parenthood Columbia Willamette

Vancouver, Washington, 97212, United States

Location

Study Officials

  • Elizabeth Raymond, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2020

First Posted

October 23, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

February 4, 2022

Record last verified: 2020-10

Locations