Transplacental Transmission of COVID-19

June 22, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France, 42000
        • CHU SAINT-ETIENNE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spike SARS-COV-2 protein in placental tissues
Time Frame: Baseline : childbirth
number of cells expressing the Spike SARS-COV-2 protein
Baseline : childbirth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACE2 receptors in placental tissues
Time Frame: Baseline : childbirth
number of cells expressing the ACE2 receptors
Baseline : childbirth
TMPRSS2 in placental tissues
Time Frame: Baseline : childbirth
number of cells expressing the TMPRSS2
Baseline : childbirth
cathepsin L in placental tissues
Time Frame: Baseline : childbirth
number of cells expressing the cathepsin L
Baseline : childbirth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

March 2, 2022

Study Completion (Actual)

March 2, 2022

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN1362021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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