Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)
NCT ID: NCT04465474
Last Updated: 2024-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2020-05-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
OTHER
Interventions
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Non Intervention
It's an observational study, no intervention involves.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Peking University First Hospital
OTHER
Hospital Universitario de Torrejón
UNKNOWN
Queen Mary Hospital, Hong Kong
OTHER
Pamela Youde Nethersole Eastern Hospital
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
Chinese University of Hong Kong
OTHER
Responsible Party
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Chiu Yee Liona Poon
Prof Poon, Chiu Yee Liona
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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COVID-MAP
Identifier Type: -
Identifier Source: org_study_id
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