跳至主要内容
临床试验/NCT04465474
NCT04465474招募中不适用

Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)

Chinese University of Hong Kong10 个研究点 分布在 3 个国家目标入组 3,000 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
10
主要终点
Seroconversion during pregnancy - At delivery

研究概览

简要总结

The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2 seroconversion in unselected pregnant women in Hong Kong; 2) determine the rate of SARS-CoV-2 infection in women presenting with miscarriage and stillbirth; 3) follow the pregnancy course and perinatal outcome of confirmed COVID-19-infected pregnant cases; 4) determine the risk and characteristics of vertical transmission; and 5) evaluate the placental barrier, immune response and fetal damage in vertical transmission of SARS-CoV-2. A series of longitudinal and cross-sectional observational studies, and a laboratory-based study will be conducted to fulfil the 5 objectives.

详细描述

With over 10 million individuals infected worldwide, the coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a global public health crisis. It is recognized that pregnant women are at an increased risk of acquiring viral respiratory infection and developing severe pneumonia due to the physiologic changes in their immune and cardiopulmonary systems. Previous studies have attempted to determine maternal and perinatal outcome and potential risk of vertical transmission in pregnant women affected by COVID-19, however, relevant clinical data and biological samples have not been collected in a systematic manner. The research project will engage in collaborative research across obstetricians/maternal-fetal medicine subspecialists, gynecologist, infectious disease specialists, pediatrician, developmental and molecular biologists and bioinformatician between the CUHK, China and Spain. The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2 seroconversion in unselected pregnant women in Hong Kong; 2) determine the rate of SARS-CoV-2 infection in women presenting with miscarriage and stillbirth; 3) follow the pregnancy course and perinatal outcome of confirmed COVID-19-infected pregnant cases; 4) determine the risk and characteristics of vertical transmission; and 5) evaluate the placental barrier, immune response and fetal damage in vertical transmission of SARS-CoV-2. A series of longitudinal and cross-sectional observational studies, and a laboratory-based study will be conducted to fulfil the 5 objectives.

Results generated will inform obstetrics and gynecology, pediatric and infectious disease scientific communities as well as public health specialists and policy makers regarding: (1) the estimated seroconversion rate in women of childbearing age; these results will help (i) improve the approach to care for pregnancy and childbirth during the COVID-19 outbreak; and (ii) formulate preventive measures to be implemented specifically for pregnant women in reducing risk of infection and associated complications to both the women and their unborn child; (2) the impact of COVID-19 on maternal and perinatal outcomes; data from high-quality research will inform practice during the COVID-19 outbreak, guiding healthcare professionals on how to adjust the management approach to infected pregnant women and the exact risks the infection poses to the babies; (3) the risk of vertical transmission at different stages of pregnancy and its sequelae; findings of this study will guide counselling, decision making and clinical management; (4) the identification of cellular site of viral entry and replication in the maternal-fetal interface that would be instrumental in designing therapeutic measures to cease vertical transmission and developing therapeutic treatments.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Seroconversion during pregnancy - At delivery

时间窗: At Delivery

Mother

Seroconversion during pregnancy - DSS1

时间窗: At DSS1 (Around 11-13 weeks gestation)

Mother

Pregnancy course and perinatal outcome

时间窗: From date of recruited until the date of delivery

Mother and Baby

Potential mechanisms for vertical transmission 1) placental barrier, 2) immune response and 3) fetal damage of vertical transmission and mechanism in SARS-CoV-2 infection.

时间窗: through study completion, up to 2 years

Mother and Baby

Vertical transmission

时间窗: At Newborn 18 months of life

Mother and Baby

Pregnancy loss

时间窗: At pregnancy loss

Mother (1st); Mother and abortus/stillborn baby(2nd)

次要结局

未报告次要终点

研究者

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

Chiu Yee Liona Poon

Prof Poon, Chiu Yee Liona

Chinese University of Hong Kong

研究点 (10)

Loading locations...

相似试验