跳至主要内容
临床试验/NCT04315870
NCT04315870Unknown不适用

Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in Pregnancy: The Italian Registry on Coronavirus in Pregnancy

Federico II University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Maternal and perinatal outcomes

研究概览

简要总结

The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease. The number of patients infected by 2019-nCoV in Italy closely followed an exponential trend, and Italy reported the highest number of infected patients and deaths in the world excluding China.

详细描述

Coronaviruses (CoVs) are the largest group of viruses belonging to the Nidovirales order. They are enveloped, non-segmented positive-sense RNA viruses.1 Coronavirus are believed to cause a significant proportion of all common colds in adults and children. The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease. The initial cases of 2019-nCoV occurred in Wuahn, China in December 2019.2 A recent review evaluated the potential impact of 2019-nCoV in pregnancy.3 The authors reported published data on CoVs in pregnant women, including 2019-nCoV, severe acute respiratory syndrome (SARS-COV) and Middle East respiratory syndrome (MERS-COV). The review included 12 women with SARS-COV,4 11 women MERS-COV,5 and 9 women with 2019-n-CoV6 in pregnancy. No cases of vertical trasmission were reported, but the authors showed an high rate of preterm birth (45.8%), cesarean delivery (70.8%), maternal admission to intensive care unit (ICU) (63.3%), and maternal death (18.8%).

The number of patients infected in Italy closely followed an exponential trend, and Italy reported the highest number of infected patients and deaths in the world excluding China.7 Therefore, Italy can be a great source of data, including data on pregnant women.

The aim of this study was to evaluate the pregnancy and perinatal outcomes of pregnant women with 2019-n-CoV.

This was a multicenter, retrospective, cohort study. Clinical records and compiled data of all consecutive hospitalized and outpatient pregnant women with laboratory-confirmed 2019-n-CoV Data on recent exposure history, clinical symptoms or signs, laboratory findings, and maternal and perinatal outcomes were collected. All medical recors were sent to the coordinator center at University of Naples Federico II. Data were entered into a computerized database and cross-checked. If the core data were missing, requests for clarification were sent to the coordinators.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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

  • pregnant women with laboratory-confirmed 2019-n-CoV

排除标准

  • 未提供

结局指标

主要结局

Maternal and perinatal outcomes

时间窗: during gestation and at the time of delivery of the baby

different maternal and perinatal outcomes were evaluated including: admission to ICU, use of mechanical ventilation, maternal death, early pregnany loss, perinatal death, intrauterine growth restriction (IUGR), preterm birth, mode of delivery, LBW, admission to neonatal ICU (NICU), and clinical or serologic evidence of vertical trasmission

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriele Saccone

principal investigator, medical doctor

Federico II University

研究点 (1)

Loading locations...

相似试验