Transplacental Transmission of COVID-19

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05124574
Collaborator
(none)
20
1
12
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Samples concern SARS-COV-2 + pregnant women at the time of childbirth
  • Other: Samples concern newborns of SARS-COV-2 + mothers at birth

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Evaluation of Transplacental Transmission of SARS-COV-2 (COVID-19) in a Cohort of 10 Mother/Child Dyads
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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,

Outcome Measures

Primary Outcome Measures

  1. Spike SARS-COV-2 protein in placental tissues [Baseline : childbirth]

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

Secondary Outcome Measures

  1. ACE2 receptors in placental tissues [Baseline : childbirth]

    number of cells expressing the ACE2 receptors

  2. TMPRSS2 in placental tissues [Baseline : childbirth]

    number of cells expressing the TMPRSS2

  3. cathepsin L in placental tissues [Baseline : childbirth]

    number of cells expressing the cathepsin L

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Social security affiliation

  • Signed informed consent

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

Exclusion Criteria:
  • Patient vaccinated within 15 days prior to inclusion

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Saint-Etienne Saint-Étienne France 42000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Hugues PATURAL, PhD, CHU SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT05124574
Other Study ID Numbers:
  • IRBN1362021
First Posted:
Nov 18, 2021
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2021