Clinical Trials Directory

Trials / Terminated

TerminatedNCT05124574

Transplacental Transmission of COVID-19

Prospective Evaluation of Transplacental Transmission of SARS-COV-2 (COVID-19) in a Cohort of 10 Mother/Child Dyads

Status
Terminated
Phase
Study type
Observational
Enrollment
10 (actual)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

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.

Detailed description

In 2021, it becomes essential to clarify if and how SARS-COV-2 reaches the fetus, in order to prevent neonatal infection, optimize pregnancy management and better understand the pathogenesis of COVID-19. SARS-COV-2, ACE2 and TMPRSS2 co-receptors are highly expressed in placental tissues and may be actively involved in transplacental transmission of the virus. From a case of materno-fetal transmission described by our team (publication in progress), we observed placental expression of the Spike SARS-COV-2 protein, but also of the ACE2 receptors, TMPRSS2 and cathepsin L. Cytotrophoblast and syncytiotrophoblast cell stains were positive within the placental villi. Maternal leukocytes were also labeled for these proteins.

Conditions

Interventions

TypeNameDescription
OTHERSamples concern SARS-COV-2 + pregnant women at the time of childbirth* 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.
OTHERSamples concern newborns of SARS-COV-2 + mothers at birth* 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,

Timeline

Start date
2021-12-01
Primary completion
2022-03-02
Completion
2022-03-02
First posted
2021-11-18
Last updated
2023-06-23

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05124574. Inclusion in this directory is not an endorsement.