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Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)

Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04465474
Enrollment
3000
Registered
2020-07-10
Start date
2020-05-01
Completion date
2024-12-31
Last updated
2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

pregnancy, vertical transmission, pregnancy loss, ACE2 TMPRSS2

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.

Interventions

OTHERNon Intervention

It's an observational study, no intervention involves.

Sponsors

Peking University First Hospital
CollaboratorOTHER
Hospital Universitario de Torrejón
CollaboratorUNKNOWN
Queen Mary Hospital, Hong Kong
CollaboratorOTHER
Pamela Youde Nethersole Eastern Hospital
CollaboratorOTHER
Queen Elizabeth Hospital, Hong Kong
CollaboratorOTHER
United Christian Hospital
CollaboratorOTHER
Kwong Wah Hospital
CollaboratorOTHER
Princess Margaret Hospital, Hong Kong
CollaboratorOTHER_GOV
Tuen Mun Hospital
CollaboratorOTHER_GOV
Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Objective 1: Seroconversion during pregnancy Inclusion criteria: * 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 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

Design outcomes

Primary

MeasureTime frameDescription
Seroconversion during pregnancy - DSS1At DSS1 (Around 11-13 weeks gestation)Mother
Seroconversion during pregnancy - At deliveryAt DeliveryMother
Pregnancy lossAt pregnancy lossMother (1st); Mother and abortus/stillborn baby(2nd)
Pregnancy course and perinatal outcomeFrom date of recruited until the date of deliveryMother and Baby
Vertical transmissionAt Newborn 0 hours of life, mother immediately after deliveryMother 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.through study completion, up to 2 yearsMother and Baby

Countries

China, Hong Kong, Spain

Contacts

Primary ContactLiona POON
liona.poon@cuhk.edu.hk(852) 3505 2582
Backup ContactEqual CHEN
equalchen@cuhk.edu.hk(852) 3505 1536

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026