DOES COVID-19 INFECTION AND/OR VACCINATION OF PREGNANT WOMEN AFFECT THE PANCREATIC BETA CELLS OF THE FETUS BECOMING A TRIGGER FOR FUTURE DEVELOPMENT OF CHILDHOOD TYPE 1 DIABETES
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Presence of anti COVID 19 antibodies in maternal and cord blood
研究概览
简要总结
The aim of this study is to check for the presence of COVID 19 antibodies [Covid-19, GAD-65, IA-2, ICA] in the blood of laboring women who have been exposed to either the virus itself or to the vaccine during pregnancy . The same test will be done on cord blood. Then the types of antibodies will be compared, between maternal and neonatal blood. The blood will be taken along with routine blood tests without additional punctures of Mother or Baby.
详细描述
T1D is caused by an autoimmune reaction to proteins that cause the destruction of the pancreatic beta cells. The incidence of childhood Type 1 diabetes (T1D) is continuously increasing, caused by environmental factors, mainly viruses (1).
The most implicated viruses are coxsackie B4 (2) and rotaviruses (3,4). In the past mumps and rubella viruses gave been found to cause early childhood T1D and the introduction of mumps and rubella vaccination have stopped this process (5).
Recently we (6) and others (7-9) have shown that Rotavirus vaccination to infants attenuates the incidence of T1D in children aged 0-5 (in press). Covid-19 has not yet been investigated.
Aim of study To determine whether anti-Covid-19 antibodies generated by infection and/or vaccination of pregnant mothers, pass the placenta and affect the fetal beta-cells, by damaging or protecting these insulin producing cells.
Subjects 100 pregnant women with Covid-19 infection or vaccination who are followed and delivered at the Mayanei HaYeshua Medical Center will be enrolled in the study.
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 48 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •exposure to the COVID 19 virus or vaccine during pregnancy
排除标准
- •Age under 18 or over 48 IUFD
结局指标
主要结局
Presence of anti COVID 19 antibodies in maternal and cord blood
时间窗: ONE YEAR
Covid-19, GAD-65, IA-2, ICA
次要结局
未报告次要终点
研究者
Mirra Manevich Mazor
OBSTETRICS & GYNECOLOGY RESIDENT
Maaynei Hayesha Medical Center
