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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Hospital Universitario de Torrejón | UNKNOWN |
| Queen Mary Hospital, Hong Kong | OTHER |
| Pamela Youde Nethersole Eastern Hospital |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Intervention | Other | It's an observational study, no intervention involves. |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion during pregnancy - DSS1 | Mother | At DSS1 (Around 11-13 weeks gestation) |
| Seroconversion during pregnancy - At delivery | Mother | At Delivery |
| Pregnancy loss | Mother (1st); Mother and abortus/stillborn baby(2nd) | At pregnancy loss |
| Pregnancy course and perinatal outcome | Mother and Baby | From date of recruited until the date of delivery |
| Vertical transmission | Mother and Baby | At Newborn 0 hours of life, mother immediately after delivery |
| Vertical transmission | Mother and Baby | At Newborn 7 days of life |
| Vertical transmission | Mother and Baby | At Newborn 14 days of life |
| Vertical transmission | Mother and Baby | At Newborn 6 months of life |
| Vertical transmission |
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Objective 1: Seroconversion during pregnancy
Inclusion criteria:
Objective 2: SARS-CoV-2 and pregnancy loss
Inclusion criteria:
•Pregnant women presenting with first and second trimester miscarriage in Hong Kong and Spain, as well as those with stillbirth during periods of 6 and 12 months, respectively.
Objective 3: Pregnancy course and perinatal outcome
Inclusion criteria:
•Pregnant women affected by COVID-19
Objective 4: Vertical transmission
Inclusion criteria:
•Pregnant women affected by COVID-19
Objective 5: Potential mechanisms for vertical transmission
Inclusion criteria:
•Pregnant women affected by COVID-19
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Pregnant women
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liona POON | Contact | (852) 3505 2582 | liona.poon@cuhk.edu.hk | |
| Equal CHEN | Contact | (852) 3505 1536 | equalchen@cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2020 | Jul 3, 2020 |
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| OTHER |
| Queen Elizabeth Hospital, Hong Kong | OTHER |
| United Christian Hospital | OTHER |
| Kwong Wah Hospital | OTHER |
| Princess Margaret Hospital, Hong Kong | OTHER_GOV |
| Tuen Mun Hospital | OTHER_GOV |
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Biological samples Miscarriage: POC, maternal blood
Stillbirth: Maternal vaginal swab, amniotic fluid, amnion-chorion interface swab, placental tissue, fetal blood, fetal throat swab, maternal blood
Delivery: Maternal blood before delivery At or after delivery: amniotic fluid, cord blood, placental tissue, amnion-chorion interface swab, neonatal throat swab Breast milk from both breasts for the duration of hospitalization Newborn throat swab at 24 hours of life Newborn stool samples for the duration of hospitalization Infant throat swab and stool sample at 7 days of age Infant blood at 14 days, 6 months & 18 months of age
Mother and Baby
| At Newborn 18 months of life |
| 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. | Mother and Baby | through study completion, up to 2 years |
| Kwong Wah Hospital | Recruiting | Hong Kong | Hong Kong |
|
| Pamela Youde Nethersole Eastern Hospital | Recruiting | Hong Kong | Hong Kong |
|
| Princess Margaret Hospital | Recruiting | Hong Kong | Hong Kong |
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| Queen Elizabeth Hospital | Recruiting | Hong Kong | Hong Kong |
|
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
|
| The Chinese University of Hong Kong, Prince of Wales Hospital | Recruiting | Hong Kong | Hong Kong |
|
| Tuen Mun Hospital | Recruiting | Hong Kong | Hong Kong |
|
| United Christian Hospital | Recruiting | Hong Kong | Hong Kong |
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| Hospital Universitario de Torrejón | Recruiting | Torrejón de Ardoz | Madrid | Spain |
|
| Prot_000.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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