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NCT04701944 Clinical Trial

Clinical Study of Pregnant Women With COVID-19

Covid-19 Clinical Trial

— PregWom-Covid  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04701944
Other study ID # 7794
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 21, 2020
Est. completion date April 21, 2021

Study information
Verified date January 2021
Source University Hospital, Strasbourg, France
Contact Philippe DERUELLE, MD, PhD
Phone 33 3 88 12 84 55
Email philippe.deruelle@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 54
Est. completion date April 21, 2021
Est. primary completion date April 21, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Department of Gynecology-Obstetrics and Fertility - Strasbourg University Hospitals Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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]
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