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identify SARS-CoV-2 infection by serologyWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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drug943 collection of biological samples Wiki 1.00

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D007239 Infection NIH 0.08

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There is one clinical trial.

Clinical Trials


1 Prevalence and Impact of SARS-COV-2 Infection in Pregnant Women, Fetuses and Newborns

A novel human coronavirus, named SevereAcute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), emerged in China, in late 2019, and is now spreading quickly causing a pandemic. It is usually responsible for a mild infectious syndrome, but patients can also develop pneumonia, acute respiratory failure and other serious complications. To date, very little and controversial literature is available on the impact of SARS-CoV-2 infection on pregnancy, and the potential risk of vertical transmission. Therefore, the first part of the study, will evaluate the proportion of pregnant woman infected by SARS-CoV-2 during pregnancy over the next six months by performing SARS-CoV-2 serology during pregnancy and at delivery . This information will be correlated to pregnancy and neonatal outcome. The second part of the study 2 will collect sera from several mandatory screening that are kept for one year. Those will be used for assessing the time of the seroconversion and variations of susceptibility to infection with gestational age as well as the impact of social distancing measures. Concerning neonates born to mothers with documented SARS-CoV-2 infection during pregnancy, only few cases of congenital infections were recently reported because of pneumonia related to SARS-CoV-2 infection and/or positive IgM at birth. It remains unclear whether neonatal infection can follow transplacental transmission of SARS-CoV-2 during pregnancy and/or through early per- and postnatal exposure, including breast-feeding. In order to investigate these hypotheses, the third part of the study will perform, SARS-CoV-2 PCR tests in a variety of samples collected from infected-mother (symptomatic during the pregnancy and PCR confirmed) and child pairs, at delivery and in the postpartum period.

NCT04355234 Pregnancy Diagnostic Test: identify SARS-CoV-2 infection by serology Biological: collection of biological samples
MeSH:Infection

Primary Outcomes

Description: Number of women who are positive for SARS-CoV-2

Measure: Seroprevalence or Number of women who are positive for SARS-CoV-2 in parturient woman

Time: at delivery

Secondary Outcomes

Description: Correlation between exposure to the virus (confirmed by serology) and its impact on pregnancy and its outcome : Pregnancy outcome, maternal or neonatal complications

Measure: Consequences of SARS-CoV-2 infection in pregnant women and their newborns : Pregnancy outcome, maternal or neonatal complications

Time: 2 months after delivery

Description: Presence of virus (objectified by PCR) in the different biological compartments tested :In the mother: vaginal, anal, amniotic fluid and in the newborn: nasopharyngeal swabs, gastric aspiration, anal swab.

Measure: Assessment of the vertical transmission of SARS-CoV-2 and the possible routes of this transmission in women who are positive for SARS-CoV-2 during pregnancy

Time: at delivery

Description: Presence of virus (objectified by PCR) in the different biological compartments tested :In the mother: milk and stool samples and in the newborn: nasopharyngeal swabs, urine and stool.

Measure: Assessment of the vertical transmission of SARS-CoV-2 and the possible routes of this transmission in women who are positive for SARS-CoV-2 during pregnancy

Time: 5 days after delivery

Description: Evaluation of gestational age at SARSCoV-2 infection by performing serology on monthly collected serum samples (samples collected for routine management of pregnancy).

Measure: Assessment of susceptibility to infection during the 3 trimesters of pregnancy

Time: 5 days after delivery

Description: Study of the methods of confinement by investigation

Measure: Evaluation of the confinement on the risk of exposure to the virus during pregnancy .

Time: 5 days after delivery

Description: A biobank will be carried out, including the collection of several biological samples at the time of maternal SARS-CoV-2 infection, at delivery and in the postpartum period in the parturient and her newborn

Measure: collection of biological samples for new investigations in women who are positive for SARS-CoV-2 during pregnancy.

Time: 5 days after delivery

Description: Risk factors in uninfected women

Measure: Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease.

Time: at delivery

Description: Risk factors in infected and symptomatic women.

Measure: Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease.

Time: at delivery

Description: risk factors in newborns

Measure: Assessment of the rate of SARS-CoV-2 infection in newborns and the risk factors for the disease.

Time: at delivery


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