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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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Non Intervention

It's an observational study, no intervention involves.

Intervention Type OTHER

Eligibility Criteria

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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


•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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role collaborator

Hospital Universitario de Torrejón

UNKNOWN

Sponsor Role collaborator

Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role collaborator

Pamela Youde Nethersole Eastern Hospital

OTHER

Sponsor Role collaborator

Queen Elizabeth Hospital, Hong Kong

OTHER

Sponsor Role collaborator

United Christian Hospital

OTHER

Sponsor Role collaborator

Kwong Wah Hospital

OTHER

Sponsor Role collaborator

Princess Margaret Hospital, Hong Kong

OTHER_GOV

Sponsor Role collaborator

Tuen Mun Hospital

OTHER_GOV

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Chiu Yee Liona Poon

Prof Poon, Chiu Yee Liona

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Kwong Wah Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Pamela Youde Nethersole Eastern Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Princess Margaret Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Queen Elizabeth Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

The Chinese University of Hong Kong, Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Tuen Mun Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

United Christian Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Hospital Universitario de Torrejón

Torrejón de Ardoz, Madrid, Spain

Site Status RECRUITING

Countries

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China Hong Kong Spain

Central Contacts

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Liona POON

Role: CONTACT

(852) 3505 2582

Equal CHEN

Role: CONTACT

(852) 3505 1536

Facility Contacts

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Huixia YANG, MD, PhD

Role: primary

Wing Cheong LEUNG, MBBS, MRCOG, FHKAM, FHKCOG

Role: primary

3517 5053

Chung Nin LEE, MBBS, MMedSc, FRCOG, FHKCOG

Role: primary

2595 6815

Tsz-Kin LO, MBBS, MRCOG, FHKCOG

Role: primary

Wei Ling Teresa MA, FRCOG, FHKAM

Role: primary

3506 2246

Ka Wang CHEUNG, MBBS, MRCOG; FHKCOG; FHKAM

Role: primary

2255 4267

Liona Chiu Yee Poon, MBBS, MRCOG, MD

Role: primary

(852) 3505 2582

Equal CHEN

Role: backup

(852) 3505 1536

Po Lam SO

Role: primary

2468 5918

Choi Wah KONG, MBChB, MRCOG, FHKAM, FHKCOG

Role: primary

3949 3444

Maria del Mar GIL, PhD

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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COVID-MAP

Identifier Type: -

Identifier Source: org_study_id

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