Clinical Study of Pregnant Women With COVID-19 (PregWom-Covid)

January 7, 2021 updated by: University Hospital, Strasbourg, France

Clinical Study of Pregnant Women With COVID-19: A Retrospective Review of Medical Records at Strasbourg University Hospitals

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Department of Gynecology-Obstetrics and Fertility - Strasbourg University Hospitals
        • Sub-Investigator:
          • Pierre Kuhn, MD
        • Contact:
        • Principal Investigator:
          • Philippe DERUELLE, MD, PhD
        • Sub-Investigator:
          • Fanny DE MARCILLAC, MD
        • Sub-Investigator:
          • Charlotte Jouffrieau, MD
        • Sub-Investigator:
          • Samira Fafi-Kremer, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant woman suffering from a confirmed or suspected COVID-19 infection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2020

Primary Completion (Anticipated)

April 21, 2021

Study Completion (Anticipated)

April 21, 2021

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7794

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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