A new coronavirus (COVID-19) highlighted at the end of 2019 in China is spreading across all continents. Most often at the origin of a mild infectious syndrome, associating benign symptoms (such as fever, cough, and headache) to different degrees, COVID-19 can cause serious pulmonary pathologies and sometimes death. Data on the consequences during pregnancy are limited. The first Chinese data published seem to show that the symptoms in pregnant women are the same as those of the general population. There are no cases of intrauterine maternal-fetal transmission, but cases of newborns infected early suggest that there could be vertical intrauterine, perpartum or neonatal transmission. Prematurity and cases of respiratory distress in newborns of infected mothers have been described. Subsequently, an in-depth analysis of cases in pregnant women and pregnancy issues are necessary in order to improve knowledge on the subject.
The main objective of this project is to set up a biological and tissue collection in order
to study the transplacental passage of the SARS-CoV-2 virus, and the pregnancy outcomes
(miscarriage, intra uterine fetal death, medical termination of pregnancy or living birth)
during COVID-19 pandemic. The biological and tissue collection will be made up of systematic
samples taken from parturient women and their pregnancy outcome at the time of their arrival
at the maternity unit to deliver whatever their term and pregnancy outcome. This inclusion
will concern all pregnant women, both symptomatic and asymptomatic positive COVID-19 women,
and negative COVID-19 women. All women included will have a serological test to check their
immunity status to SARS-CoV-2 in order to study pregnant women with an unnoticed COVID-19
infection during their pregnancy. The inclusion time will extend from the epidemic period
until a year after, in order to document the outcomes of pregnant women potentially exposed
to SARS-CoV-2 in early pregnancy. Samples analyses will be carried out after the epidemic
peak to not overload laboratories in times of crisis.
The challenge is to have a better knowledge of the SARS-CoV-2 epidemiological and virological
characteristics in particular its involvement in maternal-fetal morbidity and mortality, and
to better understand the organs affected and the pathways of contamination within this
particular mother-child duo.
Diagnostic Test: COVID 19 diagnostic test by PCR
Inclusion of patients with clinical data (in a eCRF) and various samples collection according to the outcome of pregnancy
Storage and freezing samples for subsequent analysis by RT-PCR COVID-19 (maternal saliva, cord blood, fetal stools, placenta, fetal tissue, amniotic fluid according to pregnancy outcomes) and by maternal and newborn and / or fetal serologies testing
Pathological study of placentas and fetal autopsies
Histology of positive COVID-19 placentas
Brain and visceral histology of positive COVID-19 fetuses autopsied
Analysis of patient comorbidities and comparison in the different groups
Final statistical analysis
Inclusion Criteria:
- Women over 18 years old on the date of inclusion
- Pregnant women coming to deliver in the Paule de Viguier maternity unit of Toulouse's
University Hospital between April 2020 and April 2021 regardless the pregnancy
outcomes (live births, IUFD, miscarriages, medical termination of pregnancy ) and the
term
- Women affiliated to a social security system (including AME)
Exclusion Criteria:
- Voluntary termination of pregnancy
- Language barrier
- Patient under a legal protection measure (guardianship, curatorship, or safeguard of
justice)
University Hospital of Toulouse
Toulouse, France
Charlotte Dubucs, MD, Principal Investigator
University Hospital, Toulouse