跳至主要内容
临床试验/NCT04418557
NCT04418557已完成不适用

COVID-19 and Obstetric Transmission

University Hospitals Cleveland Medical Center1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2020年4月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Presence of COVID-19 virus

研究概览

简要总结

The aim of this study is to capture data, laboratory markers, and clinical outcomes of obstetric and neonatal outcomes in cases of COVID-19 during pregnancy and of pregnancies exposed to a COVID-19 vaccine in Cuyahoga County.

详细描述

A review of the 55 cases of obstetric COVID-19 cases world-wide demonstrate the following fetal complications of COVID-19: miscarriage (2%), intrauterine growth restriction (IUGR; 10%), pre-eclampsia, and pre-term birth (39%). In Wuhan, China, nine women who were COVID-19 positive were surveilled for vertical transmission and overall obstetric and early neonatal outcomes. Amniotic fluid, umbilical cord blood, and neonatal throat swabs were collected at the time of delivery, and breastmilk samples were collected after lactation commenced. There was no viral detection of COVID-19 demonstrated.2 However, two neonates in the United Kingdom have tested positively for COVID-19 after delivery from an infected mother. Most recently, antibodies were detected (IgM and IgG) in the serum of a neonate born via cesarean delivery to a known positive mother. Therefore, vertical transmission has not been completely ruled out.

Additionally, infection at varying times of pregnancy has not been well delineated or correlated to neonatal or maternal outcomes at time of delivery. Therefore, there is a need to continue surveying and documenting clinical findings in obstetric COVID-19 cases.

This study will follow pregnant women who are diagnosed during any point of their pregnancy with COVID-19 and those who were vaccinated. during pregnancy. The aim will be to evaluate maternal and neonatal specimens for the presence of COVID-19 virus, immune and cellular response.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • COVID-19 infection at any time of the pregnancy, or presumed case by symptoms and direct contact with a positive case
  • Pregnancy documented by ultrasound

排除标准

  • COVID-19 infection before or after pregnancy
  • Person under investigation, but not a presumed or known positive case

结局指标

主要结局

Presence of COVID-19 virus

时间窗: At time of delivery

Viral presence in any of the collected specimens

次要结局

  • Presence of antibodies to COVID-19 virus(At time of delivery and 24 hours of life of the newborn)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rachel Pope

Assistant Professor

University Hospitals Cleveland Medical Center

研究点 (1)

Loading locations...

相似试验