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临床试验/NCT04860908
NCT04860908Unknown不适用

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

Maaynei Hayesha Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年4月26日最近更新:
适应症

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

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

发起方
Maaynei Hayesha Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mirra Manevich Mazor

OBSTETRICS & GYNECOLOGY RESIDENT

Maaynei Hayesha Medical Center

研究点 (1)

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