Assessment of Obstetric, Fetal and Neonatal Risks and Vertical SARS-CoV-2 Transmission During COVID-19 Pandemic (COroFet)

Assessment of Obstetric, Fetal and Neonatal Risks and Vertical SARS-CoV-2 Transmission During COVID-19 Pandemic by Creation and Analysis of a Biological and Tissue Collection of Pregnancy Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Diagnostic test: COVID 19 diagnostic test by PCR

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 2494
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31000
    • University Hospital of Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Unexposed group : COVID 19 negatif pregant woman; COVID-19 negative women (not immunize	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 autopsiesHistology of positive COVID-19 placentasBrain and visceral histology of positive COVID-19 fetuses autopsied; Analysis of patient comorbidities and comparison in the different groups; Final statistical analysis
Other: Exposed group : COVID 19 positif pregant woman; Women positive for COVID-19 (symptomatic and asymptomatic) COVID-19 negative women with long-standing immunity	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 autopsiesHistology of positive COVID-19 placentasBrain and visceral histology of positive COVID-19 fetuses autopsied; Analysis of patient comorbidities and comparison in the different groups; Final statistical analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of positive COVID-19 women	Exposure to SARS-CoV-2 will be measured the day of delivery by RT-PCR on maternal saliva and by serology on maternal blood	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of positive COVID-19 women	Description of the number of positive COVID-19 RT-PCRs in the conception products: amniotic fluid, frozen placenta fragment, frozen fetal tissue, cord blood or frozen cord fragment	Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Charlotte Dubucs, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2020
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; pandemic; Pregnant women; vertical mother-fetal transmission
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RC31/20/0123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No