Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)
1 other identifier
observational
3,000
3 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
July 3, 2020
CompletedFirst Posted
Study publicly available on registry
July 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFebruary 8, 2024
February 1, 2024
4 years
July 3, 2020
February 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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
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
Interventions
It's an observational study, no intervention involves.
Eligibility Criteria
Pregnant women
You may qualify if:
- Pregnant women who attended for Down syndrome screening (DSS) at 11-13 weeks
- Had serum sample taken between 1 November 2019 and 1 June 2020 consented for stored serum for future research
- Intended to deliver at the booking hospital.
- Objective 2: SARS-CoV-2 and pregnancy loss
- 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
- Pregnant women affected by COVID-19
- Objective 4: Vertical transmission
- Pregnant women affected by COVID-19
- Objective 5: Potential mechanisms for vertical transmission
- Pregnant women affected by COVID-19
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese University of Hong Konglead
- Peking University First Hospitalcollaborator
- Hospital Universitario de Torrejóncollaborator
- Queen Mary Hospital, Hong Kongcollaborator
- Pamela Youde Nethersole Eastern Hospitalcollaborator
- Queen Elizabeth Hospital, Hong Kongcollaborator
- United Christian Hospitalcollaborator
- Kwong Wah Hospitalcollaborator
- Princess Margaret Hospital, Hong Kongcollaborator
- Tuen Mun Hospitalcollaborator
Study Sites (10)
Peking University First Hospital
Beijing, Beijing Municipality, China
Kwong Wah Hospital
Hong Kong, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
Princess Margaret Hospital
Hong Kong, Hong Kong
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
United Christian Hospital
Hong Kong, Hong Kong
Hospital Universitario de Torrejón
Torrejón de Ardoz, Madrid, Spain
Biospecimen
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof Poon, Chiu Yee Liona
Study Record Dates
First Submitted
July 3, 2020
First Posted
July 10, 2020
Study Start
May 1, 2020
Primary Completion
April 30, 2024
Study Completion
December 31, 2024
Last Updated
February 8, 2024
Record last verified: 2024-02