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Maternal Fetal Infection TransmissionTMF-COVID-19NCT04395924

Maternal-foetal Transmission of SARS-Cov-2

An observational study of Maternal Fetal Infection Transmission and COVID-19, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

One case of maternal-fetal transmission of SARS Cov-2 was published (1). Ig M and Ig G were found at two hours after birth of a new born from a mother COVID-19. Another study on few newborns COVID-19 reported that the SARS-Cov-2 was not transmitted in utero but only after birth. Read more about this study

Who is it for?
Ages 18 to 48 years, women only
What is being tested?
Diagnosis of SARS-Cov2 by RT-PCR and : IgG, Ig M serologies in the amniotoc fluid, the blood cord and the placenta
How many people
50 participants
Where
1 siteFrance
Study dates
5 May 2020to 4 May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 48 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Pregnant women COVID-19 positive or with suspected infection or presented a positive SARS Cov-2 PCR or serologies at any moment of the pregnancy. Symptomatic and asymptomatic pregnant women with SARS-Cov-2 will be included.

Who may be able to join

  • All pregnant women SARS-Cov-2 positive during the pregnancy
  • Informed consent obtained
  • 18 years to 48 years

Who cannot join

  • Pregnant women without SARS-Cov-2 infection ( PCR test and or serologies negatives)
  • curatorship patients.
  • Refusal to participate to the study

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHR Orléans

    Orléans

Other trials in France

About this study

Official title: Maternal-Foetal Transmission of COVID-19

One case of maternal-fetal transmission of SARS Cov-2 was published (1). Ig M and Ig G were found at two hours after birth of a new born from a mother COVID-19. Another study on few newborns COVID-19 reported that the SARS-Cov-2 was not transmitted in utero but only after birth.

Although there are few data on COVID-19 during pregnancy, according to our national data collections, it appears to be responsible for miscarriages and fetal deaths. There are also intrauterine growth restrictions and an increase of the rate of cesarean sections for maternal indications. Therefore, it is essential to know if there is a maternal viremia which infects the fetus because the consequences in terms of management would be completely different.

Read more

In fact, the potential intrauterine infection will lead to antenatal monitoring of these patients with an antenatal diagnosis and may be a treatment.

Therefore, it seems essential to explore the mode of transmission to the newborn since many newborns have COVID-19 infection The investigators will propose to all pregnant women SARS- Cov-2 positive to perform PCR SARS-Cov-2 tests and /or serology's (IgM and Ig G) on the amniotic fluid, the blood cord and the placenta.

Read the detailed description

Pregnant women SARS cov-2 positives during pregnancy or during labor tested by a RT-PCR SARS-Cov-2 on nasopharyngeal swabs and/or by serologies.

After informed consent the ivestigators will proceed during labor to:

  1. A vaginal swab of amniotic fluid during the rupture of the water pocket during labor.
  2. a blood sample from the umbilical cord after delivery of the newborn and clamping and sectioning of the cord. PCR Covid-19 and serologies (Ig M and Ig G) as well as investigating viral proteome and cytokines. These are additional samples in addition to the routine samples which have no impact and without risk for the mother the newborn since they are taken after delivery from the side of the placenta after clamping and sectioning of the cord.
  3. Samples of 2 fragments of placenta after delivery of the placenta for COVID-19 research, which usually goes to waste or to pathology depending on the clinical context or for infectious tests. In all cases, samples of 3 to 4 cm3 will be taken which will in no way interfere with current analyzes carried out on the placenta which weighs one third of the fetal weight on average. A viral search by COVID-19 PCR will be carried out on the placenta fragment and another part will be frozen for analysis by electron microscopy and study of the viral proteome, cytokines and immune mechanisms. Placenta samples will be frozen at -80 degrees.
Being tested
Diagnosis of SARS-Cov2 by RT-PCR and : IgG, Ig M serologies in the amniotoc fluid, the blood cord and the placenta
Keywords
Pregnancy, RT-PCR-COVID-19, SARS-CoV 2 serologies, Placenta, Blood cord, Amniotic fluid
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnosis of SARS-Cov2 by RT-PCR and : IgG, Ig M serologies in the amniotoc fluid, the blood cord and the placentaDiagnostic test

    During labor and delivery

    1. Sample of amniotic fluid
    2. 2 samples of blood cord after the birth of the new born
    3. 2 samples of placenta

    These samples will be tested with A RT-PCR COVID-19 test and / or serology's A sample of blood cord and placenta will be frozen at -80 degree C and studied for PCR and viral proteome, cytokines , D-dimers and others inflammatory markers in the PRIMMO Laboratory (Prof. TOUMI and LESPESSAILLES) and after in the Centre of molecular biophysics of CNRS of Orleans (Prof. PICHON)

Study groups in NCT04395924
Study groupRoleWhat they receive
Pregnant women COVID-19 positive by RT-PCRPregnant women COVID-19 positive by RT-PCR on nasopharyngeal swabs and/or by serology or with previous history of SARS-Cov-2 positive during the pregnancy coming to the maternity to deliver
Receives: Diagnostic Test: Diagnosis of SARS-Cov2 by RT-PCR and : IgG, Ig M serologies in the amniotoc fluid, the blood cord and the placenta

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. COVID-19 by positive PCR in cord blood and / or positive serologies

    COVID-19 by positive PCR in cord blood and / or positive serologies

    Measured: Day 0

Secondary outcomes (2)

  1. COVID-19 by positive PCR in amniotic fluid and placenta

    COVID-19 by positive PCR in amniotic fluid and placenta

    Measured: Day 0

  2. New born infected by COVID-19

    Newborn baby infected with COVID-19 on gastric tubing, rectal sample, nasopharyngeal samples by COVID-19 PCR and blood samples by serology

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2020
  2. Study start5 May 2020
  3. Primary completion4 May 2021
  4. Study completion4 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04395924
Sponsor's protocol ID
CHRO-2020-10
Acronym
TMF-COVID-19
Status last verified
Jun 2021
First submitted
19 May 2020
Last updated
15 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dong L, Tian J, He S, Zhu C, Wang J, Liu C, Yang J. Possible Vertical Transmission of SARS-CoV-2 From an Infected Mother to Her Newborn. JAMA. 2020 May 12;323(18):1846-1848. doi: 10.1001/jama.2020.4621.

    PubMed 32215581

  • Sutton D, Fuchs K, D'Alton M, Goffman D. Universal Screening for SARS-CoV-2 in Women Admitted for Delivery. N Engl J Med. 2020 May 28;382(22):2163-2164. doi: 10.1056/NEJMc2009316. Epub 2020 Apr 13. No abstract available.

    PubMed 32283004

  • Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, Tan W. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. 2020 May 12;323(18):1843-1844. doi: 10.1001/jama.2020.3786.

    PubMed 32159775

  • Woo PC, Lau SK, Wong BH, Tsoi HW, Fung AM, Chan KH, Tam VK, Peiris JS, Yuen KY. Detection of specific antibodies to severe acute respiratory syndrome (SARS) coronavirus nucleocapsid protein for serodiagnosis of SARS coronavirus pneumonia. J Clin Microbiol. 2004 May;42(5):2306-9. doi: 10.1128/JCM.42.5.2306-2309.2004.

    PubMed 15131220

Questions about this trial

What is this clinical trial studying?

An observational study of Maternal Fetal Infection Transmission and COVID-19, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COVID-19 by positive PCR in cord blood and / or positive serologies (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04395924, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.

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