Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04355234 |
| Other study ID # |
APHP 200448 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 4, 2020 |
| Est. completion date |
August 31, 2021 |
Study information
| Verified date |
April 2020 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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. Currently we do not know how many pregnant women
may be infected by SARS-CoV-2 and if, as for influenza, they might more likely develop severe
infection.
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.
