Prospective Study of Maternal and Umbilical Cord Blood Collection to Evaluate for Presence of COVID-19 Antibody Response in COVID-19 Positive Women
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Presence of COVID-19 IgG antibodies by immunoassay in maternal and cord blood samples.
研究概览
简要总结
Protocol Summary
Study design: Prospective cohort study of pregnant COVID-19 positive patients at delivery.
Study Objective: To collect umbilical cord blood and placenta samples at the time of delivery in COVID-19 positive women and evaluate for presence of COVID-19 virus and maternal antibody response.
Inclusion/Exclusion Criteria: Women admitted for delivery who are known or suspected COVID-19 positive who have had standard nasal swab testing for COVID-19.
Study Procedures: Informed consent for patients will be obtained. Maternal blood will be collected for viral and antibody tests for COVID-19. Following delivery of the neonate, cord blood and placenta samples will be collected and sent for viral PCR and maternal antibody analysis. Neonatal testing will be done as per existing clinical protocol for infants born to PUI/COVID-19 positive women.
Statistical Analysis: Statistical analysis for this study will include descriptive analysis and quantitative statistics of findings.
详细描述
Background
The clinical syndrome of coronavirus 2019 (COVID-19), caused by the severe acute respiratory 2 virus (SARS-CoV-2) first began in Wuhan China in December 2019 and subsequently spread globally at an exponential rate. The disease was officially classified by the World Health Organization as a pandemic on March 11, 2020. The first death from COVID-19 was reported in the United States on February 28, 2020.
In general, pregnancy is a state of relative immunosuppression, and alterations in immunology and physiology during pregnancy increase the risks of significant respiratory complications and associated obstetrical complications from severe illness. To date, data to guide understanding of the impact of COVID-19 on pregnancy is relatively limited. With any viral illness in pregnancy, there is potential for maternal-fetal transmission. As of now, there have been very few reported cases of suspected vertical transmission. Moreover, there have been few cases of neonatal transmission, even in patients acutely ill with COVID-19 at the time of delivery. However, a recent case report highlighted a 19 week pregnancy loss in a COVID-19 positive patient where placenta pathology showed presence of COVID-19 by PCR, although fetal samples were negative.
As the United States begins to expand testing from viral to antibody testing, opportunity exists to determine if maternal antibodies are present in neonates. If present, these antibodies may confer protection for neonates born to infected mothers. During the course of any infection, IgM antibodies are formed with subsequent development of IgG antibodies. Regardless of source, maternal IgM antibodies do not readily cross the placenta barrier, while maternal IgG antibodies easily cross the placenta during pregnancy. Fetuses are capable of initiating an IgM response to infection in utero. Cord blood serves as a non-invasive source of neonatal blood that can be easily obtained at delivery and allows assessment of the neonate.
Hypothesis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women admitted for delivery who are known or suspected COVID-19 positive and women were positive at any time during pregnancy who have had standard nasal swab PCR testing for COVID-19.
排除标准
- •Patients less than 18 years of age. Patients unable to give consent. Patients who are immunocompromised.
结局指标
主要结局
Presence of COVID-19 IgG antibodies by immunoassay in maternal and cord blood samples.
时间窗: 6 months
Immunoassay will be used to detect qualitative levels of COVID-19 IgG antibodies in maternal and cord blood.
次要结局
未报告次要终点