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临床试验/NCT04362956
NCT04362956已完成不适用

Clinical and Immunologic Impact of SARS-CoV-2 in Hospitalized Pregnant Women and Neonates in Argentina

Fundacion Infant1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2020年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
114
试验地点
1
主要终点
Vertical transmission

研究概览

简要总结

This is a multi-center prospective study that aims to investigate the clinical and immunologic impact of SARS-CoV-2 infection in pregnant women and neonates. The goal is to recruit 200 SARS-CoV-2 infected pregnant women starting at 24 weeks of gestation in a neonatal network of 45.000 birth a year. Clinical data will be collected from women and neonates. Upper airways samples will be obtained from both for bio-markers investigation. Finally, maternal and umbilical cord serum and human milk will be obtained for antibody assessment.

详细描述

COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, has led to an unprecedented global pandemic affecting persons of all ages. Pregnant women are in a physiologic immunosuppressed situation and have a greater risk and severity of respiratory infection. However, considerable uncertainty exists regarding the potential for vertical transmission (prenatal/congenital or perinatal) of SARS-CoV-2 from infected pregnant women to their newborns and its potential clinical consequences.

This study attempts to provide evidence-based guidelines for managing antenatal, intrapartum, and neonatal care around COVID-19 require an understanding of whether the virus can be transmitted transplacentally; a determination of which maternal body fluids may be infectious; trasnplacental and human milk antibody transfer and data of adequate statistical power that describe which maternal, intrapartum, and neonatal factors influence perinatal transmission.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant women hospitalized presenting with:
  • Fever with one or more respiratory symptoms (cough, odinophagia, respiratory difficulty)
  • Diagnoses of pneumonia with no other explainable cause.

排除标准

  • 未提供

结局指标

主要结局

Vertical transmission

时间窗: 96 hours from birth

Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate

Neonatal protection due to maternal antibodies

时间窗: 24 weeks of gestation to birth

Presence of IgG in umbilical cord

次要结局

  • Increase risk of obstetric complications(Up to 14 days of hospitalization)
  • Increase risk of neonatal morbidity(up to 30 days of life)

研究者

发起方
Fundacion Infant
申办方类型
Other
责任方
Sponsor

研究点 (1)

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