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Simplified Medical Abortion Screening: A Pilot Demonstration Project

Sponsor
Gynuity Health Projects (Other)
Overall Status
Completed
CT.gov ID
NCT02381223
Collaborator
(none)
409
Enrollment
5
Locations
22.1
Duration (Months)
81.8
Patients Per Site
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to collection additional data on the safety and acceptability of medical abortion without pretreatment pelvic ultrasound or exam in woman who meet certain criteria.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    409 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Simplified Medical Abortion Screening: A Pilot Demonstration Project
    Study Start Date :
    Mar 1, 2015
    Actual Primary Completion Date :
    Jan 1, 2017
    Actual Study Completion Date :
    Jan 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of serious adverse events [7 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion criteria:
    • Women having medical abortion

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Carafem Friendship Heights Maryland United States 20815
    2 Planned Parenthood Minnesota, North Dakota, South Dakora Minneapolis Minnesota United States 55114
    3 Institute for Family Health New York New York United States 10003
    4 Centro de Salud Mexico-Espana Mexico Distrito Federal Mexico
    5 Reproductive Health Training Center Chisinau Moldova, Republic of

    Sponsors and Collaborators

    • Gynuity Health Projects

    Investigators

    • Principal Investigator: Elizabeth Raymond, MD, Gynuity Health Projects

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gynuity Health Projects
    ClinicalTrials.gov Identifier:
    NCT02381223
    Other Study ID Numbers:
    • 1020
    First Posted:
    Mar 6, 2015
    Last Update Posted:
    May 1, 2017
    Last Verified:
    Apr 1, 2017

    Study Results

    No Results Posted as of May 1, 2017