Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04465474 |
| Other study ID # |
COVID-MAP |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2020 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Chinese University of Hong Kong |
| Contact |
Liona POON |
| Phone |
(852) 3505 2582 |
| Email |
liona.poon[@]cuhk.edu.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
