Clinical trial NCT04395924: Maternal-foetal Transmission of SARS-Cov-2
Official title: Maternal-Foetal Transmission of COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal Fetal Infection Transmission
COVID-19
SARS-CoV 2
Keywords: Pregnancy
RT-PCR-COVID-19
SARS-CoV 2 serologies
Placenta
Blood cord
Amniotic fluid
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
Collaborators: name: Centre de Biophysique Moléculaire - Pr Chantal Pichon
name: Professeur TOUMI Hechmi
First posted: 2020-05-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: COVID-19 by positive PCR in cord blood and / or positive serologies
timeFrame: Day 0
Secondary outcomes:
measure: COVID-19 by positive PCR in amniotic fluid and placenta
timeFrame: Day 0
measure: New born infected by COVID-19
timeFrame: Day 0
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR Orléans
Study officials:
affiliation: CHR ORLEANS
name: Souhail ALOUINI, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. No abstract available.
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.
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. doi: 10.1128/JCM.42.5.2306-2309.2004.