Transplacental Transmission of COVID-19

NCT05124574 | Terminated

• 1 other identifier: IRBN1362021
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

SARS-CoV-2, the agent responsible for pandemic COVID-19 infection, is transmitted mainly by respiratory droplets. Regarding maternal-fetal transmission, even if the mode of transmission from mother to fetus is not clear, some cases of perinatal transmission have been described, but without certainty on the routes of placental contamination, trans-cervical or by environmental exposure. . The case described by J. Vivanti of a newborn with neonatal neurological involvement and whose mother had been infected during the last trimester of pregnancy reports possible transplacental transmission in a context of positive and elevated viremia in the mother and positive viremia in the newborn.

Conditions

SARS-COV-2 Infection

Keywords

immune response; SARS-COV-2; ACE2 receptors; MPRSS2; cathepsin L

Outcome Measures

Primary Outcomes (1)

• Spike SARS-COV-2 protein in placental tissues

  number of cells expressing the Spike SARS-COV-2 protein

  Baseline : childbirth

Secondary Outcomes (3)

• ACE2 receptors in placental tissues

  Baseline : childbirth

• TMPRSS2 in placental tissues

  Baseline : childbirth

• cathepsin L in placental tissues

  Baseline : childbirth

Study Arms (1)

mothers infected with SARS-COV-2 at the time of delivery.

Maternal-fetal transmission of SARS-COV-2 is likely and may require co-expression of the virus receptor (ACE2) and at least one activator of virus internalization (TMPRSS2 and/or cathepsin) in a cell to make it susceptible to SARS-COV-2 infection. To confirm these hypotheses, it is necessary to explore these mechanisms of fetal transmission in a larger number of mothers infected with SARS -CoV-2 at the time of delivery. Informed information will be given in the delivery room, initially orally by the midwives, to any mother presenting with an SARS-COV-2 infection (symptomatic or not) (whatever the variant involved). An information leaflet will also be given to the patient and consent will be systematically obtained.

Other: Samples concern SARS-COV-2 + pregnant women at the time of childbirth; Other: Samples concern newborns of SARS-COV-2 + mothers at birth

Interventions

Samples concern SARS-COV-2 + pregnant women at the time of childbirth OTHER

* nasopharyngeal PCR in the mother (performed systematically in this epidemic context), * Blood samples: 1 EthyleneDiamineTetraacetic Acid (EDTA) tube (immunohistochemistry), 1 yellow tube (COVID + RT-qPCR serology). * Sampling of amniotic fluid in case of cesarean section * Sampling of the placenta for histological and virological study.

mothers infected with SARS-COV-2 at the time of delivery.

Samples concern newborns of SARS-COV-2 + mothers at birth OTHER

* In the birth room: * Collection of gastric fluid (PCR SARS-COV-2), * Cord blood: 1 EDTA tube (immunohistochemistry), 1 yellow tube (SARS-COV-2 + RT-qPCR serology). * In the newborn at D3 of life: \- 1 yellow tube (SARS-COV-2 + RT-qPCR serology) at the same time as the DNN. * In symptomatic newborns: * 1 yellow tube (SARS-COV-2 + RT-qPCR serology). * nasopharyngeal PCR,

mothers infected with SARS-COV-2 at the time of delivery.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant woman with proven SARS-COV-2 infection during full-term delivery

You may qualify if:

• Social security affiliation
• Signed informed consent
• Pregnant woman with proven SARS-COV-2 infection during full-term delivery

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

PCR nasopharyngeal, blood (serology SARS-COV-2 and RT-qPCR), placental tissues (see details)

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hugues PATURAL, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 18, 2021
• Study Start: December 1, 2021
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)