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Clinical Trials/NCT04465474
NCT04465474
Recruiting
Not Applicable

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 sites in 3 countries3,000 target enrollmentMay 1, 2020
ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Chinese University of Hong Kong
Enrollment
3000
Locations
10
Primary Endpoint
Seroconversion during pregnancy - At delivery
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2020
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chiu Yee Liona Poon

Prof Poon, Chiu Yee Liona

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Seroconversion during pregnancy - At delivery

Time Frame: At Delivery

Mother

Seroconversion during pregnancy - DSS1

Time Frame: At DSS1 (Around 11-13 weeks gestation)

Mother

Pregnancy course and perinatal outcome

Time Frame: 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.

Time Frame: through study completion, up to 2 years

Mother and Baby

Vertical transmission

Time Frame: At Newborn 18 months of life

Mother and Baby

Pregnancy loss

Time Frame: At pregnancy loss

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

Study Sites (10)

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