Clinical trial NCT04355234: Prevalence and Impact of COVID-19 Infection in Pregnant Women, Fetuses and Newborns
Official title: Prevalence and Impact of SARS-COV-2 Infection in Pregnant Women, Fetuses and Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: pregnancy; SARS-CoV-2; COVID-19
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 2446
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, open study with inclusions of 2200 parturients. All parturients divided into 2 groups:

* 2200 patients whose SARS-Cov-2 status is unknown during pregnancy
* 300 patients who presented a SARS-CoV-2 infection confirmed by PCR during pregnancy whatever the term
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Any pregnant woman giving birth or having a miscarriage after 15 weeks.
* Major patient

Exclusion Criteria:

* Patients not speaking French and not accompanied by a translator
* Patients under curatorship / guardianship
* Refusal to participate in research

Primary outcomes:
measure: Seroprevalence or Number of women who are positive for SARS-CoV-2 in parturient woman
timeFrame: at delivery
Secondary outcomes:
measure: Consequences of SARS-CoV-2 infection in pregnant women and their newborns : Pregnancy outcome, maternal or neonatal complications
timeFrame: 2 months after delivery
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
timeFrame: at delivery
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
timeFrame: 5 days after delivery
measure: Assessment of susceptibility to infection during the 3 trimesters of pregnancy
timeFrame: 5 days after delivery
measure: Evaluation of the confinement on the risk of exposure to the virus during pregnancy .
timeFrame: 5 days after delivery
measure: collection of biological samples for new investigations in women who are positive for SARS-CoV-2 during pregnancy.
timeFrame: 5 days after delivery
measure: Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease.
timeFrame: at delivery
measure: Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease.
timeFrame: at delivery
measure: Assessment of the rate of SARS-CoV-2 infection in newborns and the risk factors for the disease.
timeFrame: at delivery
Other outcomes:
Locations:
city: Paris
country: France
facility: Tsastaris Vassillis
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Christelle Vauloup Fellous
role: PRINCIPAL_INVESTIGATOR
References: