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
| Type | Name | Description |
|---|---|---|
| OTHER | Samples 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. |
| OTHER | Samples 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.