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PregWom-Covid: Clinical Study of Pregnant Women With COVID-19

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT04701944
Collaborator
(none)
54
Enrollment
1
Location
12
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A new pandemic, COVID-19, has spread rapidly around the world. She does not spare pregnant women. Little is known about the clinical course of pregnant women infected with COVID-19. As of April 1, 2020, six case series and one case report for a total of 61 pregnancies affected by COVID-19, all from the pandemic epicenter in China, except for one state case report -Unis, have been published. These preliminary reports suggest that pregnant women are not more seriously affected than the general population and show a certain gap with what we have observed in the care of pregnant women at HUS. For these reasons, additional information, especially from parts of the world other than China, as the severity of the disease can vary from country to country, is urgently needed to determine whether pregnant women with the disease of COVID-19 will not present with severe pneumonia to COVID-19.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    54 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Clinical Study of Pregnant Women With COVID-19: A Retrospective Review of Medical Records at Strasbourg University Hospitals
    Actual Study Start Date :
    Apr 21, 2020
    Anticipated Primary Completion Date :
    Apr 21, 2021
    Anticipated Study Completion Date :
    Apr 21, 2021

    Outcome Measures

    Primary Outcome Measures

    1. A retrospective review of the medical records of pregnant women with COVID-19 at the University Hospitals of Strasbourg [Files analysed retrospectively from March 01, 2020 to April 30, 2020 will be examined]]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Inclusion criteria:

    • Adult woman (≥18 years old)

    • Pregnant woman

    • Suffering from a confirmed or suspected COVID-19 infection

    • Patient who has been medically treated at Strasbourg University Hospitals as well as for his newborn baby, between 03/01/2020 and April 30, 2020

    • Woman having given, after information, her agreement for the reuse of her data for the purposes of this research

    Exclusion criteria:

    • Patient who expressed her opposition to participating in the study

    • Patient under guardianship or under guardianship

    • Patient under legal protection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Gynecology-Obstetrics and Fertility - Strasbourg University Hospitals Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Study Director: Philippe DERUELLE, MD, PhD, Department of Gynecology-Obstetrics and Fertility - Strasbourg University Hospitals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT04701944
    Other Study ID Numbers:
    • 7794
    First Posted:
    Jan 8, 2021
    Last Update Posted:
    Jan 8, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    COVID-19
    COVID-19 Pandemic
    Sars-cov-2
    Pregnant women
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jan 8, 2021