Prevalence and Impact of COVID-19 Infection in Pregnant Women, Fetuses and Newborns

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Diagnostic Test: identify SARS-CoV-2 infection by serology
* Biological: collection of biological samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: all patients<br> | Diagnostic Test: identify SARS-CoV-2 infection by serology<br>* Blood samples at delivery to identify SARS-CoV-2 infection by serology<br>|
| Experimental: patients who presented a SARS-CoV-2 infection confirmed by PCR<br> | Biological: collection of biological samples<br>* Creation of a specific collection of biological samples for new investigations thanks to 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprevalence or Number of women who are positive for SARS-CoV-2 in parturient woman | Number of women who are positive for SARS-CoV-2 | at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consequences of SARS-CoV-2 infection in pregnant women and their newborns : Pregnancy outcome, maternal or neonatal complications | Correlation between exposure to the virus (confirmed by serology) and its impact on pregnancy and its outcome : Pregnancy outcome, maternal or neonatal complications | 2 months after delivery | 
| 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 | 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. | at delivery | 
| 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 | 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. | 5 days after delivery | 
| Assessment of susceptibility to infection during the 3 trimesters of pregnancy | Evaluation of gestational age at SARSCoV-2 infection by performing serology on monthly collected serum samples (samples collected for routine management of pregnancy). | 5 days after delivery | 
| Evaluation of the confinement on the risk of exposure to the virus during pregnancy . | Study of the methods of confinement by investigation | 5 days after delivery | 
| collection of biological samples for new investigations in women who are positive for SARS-CoV-2 during pregnancy. | 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 | 5 days after delivery | 
| Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease. | Risk factors in uninfected women | at delivery | 
| Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease. | Risk factors in infected and symptomatic women. | at delivery | 
| Assessment of the rate of SARS-CoV-2 infection in newborns and the risk factors for the disease. | risk factors in newborns | at delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy; SARS-CoV-2; COVID-19