Prevalence and Impact of SARS-COV-2 Infection in Pregnant Women, Fetuses and Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,446
- 试验地点
- 1
- 主要终点
- Seroprevalence or Number of women who are positive for SARS-CoV-2 in parturient woman
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any pregnant woman giving birth or having a miscarriage after 15 weeks.
- •Major patient
排除标准
- •Patients not speaking French and not accompanied by a translator
- •Patients under curatorship / guardianship
- •Refusal to participate in research
结局指标
主要结局
Seroprevalence or Number of women who are positive for SARS-CoV-2 in parturient woman
时间窗: at delivery
Number of women who are positive for SARS-CoV-2
次要结局
- collection of biological samples for new investigations in women who are positive for SARS-CoV-2 during pregnancy.(5 days 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(5 days after delivery)
- Consequences of SARS-CoV-2 infection in pregnant women and their newborns : Pregnancy outcome, maternal or neonatal complications(2 months after delivery)
- Evaluation of the confinement on the risk of exposure to the virus during pregnancy .(5 days after delivery)
- Assessment of susceptibility to infection during the 3 trimesters of pregnancy(5 days after delivery)
- Assessment of the rate of SARS-CoV-2 infection in newborns and the risk factors for the disease.(at delivery)
- Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease.(at delivery)