COVID-19 and Pregnancy: Placental and Immunological Impacts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Placental histological evaluation
研究概览
简要总结
The aim of this study is to compare placental pathologies in patients with COVID 19 infection at the time of childbirth or a history of COVID 19 during pregnancy versus control patients
详细描述
The second wave of COVID 19 is currently sweeping through Europe. If the first wave brought reassuring elements on the risk of maternal-fetal transmission, it nevertheless counted an increase in severe maternal forms in the third trimester associated with more premature deliveries and cesarean sections. In addition, due to the very recent nature of this new infection, we have little data on the effect of SARS-COV 2 contracted during pregnancy on the fetus and on maternal-fetal exchanges.
Publications report an increase in growth retardation, maternal coagulopathies, preeclampsia and placental thrombosis. The vascular placental abnormalities observed in the first series must be confirmed and refined. Finally, pregnancy is marked by immunomodulation which can interfere with immune reactions. A better understanding of the immunological mechanisms in the mother and of the immunity transmitted to the fetus is necessary to better understand the maternal-fetal issues of COVID 19.
This prospective study concerns patients presenting for their delivery at Foch Hospital.
4 groups of patients will be identified in the delivery room after childbirth based on their COVID 19 PCR taken within 72 hours, their COVID 19 serology, or a history of positive COVID 19 PCR during pregnancy : 1 control group of 50 patients, 1 group of 50 asymptomatic patients, 1 group of 50 patients with symptoms, and 1 group of 50 cured patients who contracted the disease during pregnancy. The patients will have various samples: blood, umbilical cord blood, umbilical cord, placenta
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patient pregnant for more than 20 weeks with amenorrhea
- •Having completed a COVID 19 PCR within 72 hours
- •Admitted to the birthing room at Foch hospital for her delivery
排除标准
- •Minor (age <18 years, on inclusion)
- •Diabetes with and without insulin (only for the control group)
- •High blood pressure (only for the control group),
- •Preeclampsia (only for the control group)
- •Infection during pregnancy: HIV, toxoplasmosis, rubella, CMV, syphilis.
- •PCR Influenza A or B positive, proven by nasopharyngeal swab in the week preceding childbirth
结局指标
主要结局
Placental histological evaluation
时间窗: Delivery Day 0-Day1
vascular hypoperfusion on the fetal and maternal side, thrombosis and other abnormalities
次要结局
- Number of immunoglobulins in maternal and fetal blood(Delivery Day 0 - Day 1)
- Cellular analysis on maternal blood and cord blood: functional activities from PBMCs and NFS with the characterization of lymphocyte populations by the CytodiffTM technique(Delivery Day 0 - Day 1)
- Foetal clinical evaluation then neonatal on medical file and telephone questionnaire 1 month after childbirth. Comparison of results between groups.(1 month postpartum Day 30)
- Cellular analysis on maternal blood and cord blood: phenotyping from PBMCs and NFS with the characterization of lymphocyte populations by the CytodiffTM technique(Delivery Day 0 - Day 1)
- Number of cytokines in maternal blood and cord blood(Delivery Day 0 - Day 1)
- Maternal clinical evaluation then neonatal on medical file and telephone questionnaire 1 month after childbirth. Comparison of results between groups.(1 month postpartum Day 30)