Maternal-foetal Transmission of SARS-Cov-2

COVID-19 Clinical Trial

— TMF-COVID-19  

Official title:

Maternal-Foetal Transmission of COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04395924
• Other study ID #: CHRO-2020-10
• Status: Completed
• Start date: May 5, 2020
• Est. completion date: May 4, 2021

Study information

• Verified date: June 2021
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

• All pregnant women SARS-Cov-2 positive during the pregnancy

• Informed consent obtained

• 18 years to 48 years

Exclusion Criteria:

• Pregnant women without SARS-Cov-2 infection ( PCR test and or serologies negatives)

• curatorship patients.

• Refusal to participate to the study

Related Conditions & MeSH terms

• COVID-19
• Maternal Fetal Infection Transmission
• SARS-CoV 2

Intervention

Diagnostic Test:
• Diagnosis of SARS-Cov2 by RT-PCR and : IgG, Ig M serologies in the amniotoc fluid, the blood cord and the placenta
During labor and delivery Sample of amniotic fluid 2 samples of blood cord after the birth of the new born 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)

Locations

Country	Name	City	State
France	CHR Orléans	Orléans

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans	Centre de Biophysique Moléculaire - Pr Chantal Pichon, Professeur TOUMI Hechmi

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 by positive PCR in cord blood and / or positive serologies	COVID-19 by positive PCR in cord blood and / or positive serologies	Day 0
Secondary	COVID-19 by positive PCR in amniotic fluid and placenta	COVID-19 by positive PCR in amniotic fluid and placenta	Day 0
Secondary	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	Day 0