Clinical trial NCT04465474: Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)
Official title: Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: pregnancy
vertical transmission
pregnancy loss
ACE2 TMPRSS2
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Hospital Universitario de Torrejón
name: Queen Mary Hospital, Hong Kong
name: Pamela Youde Nethersole Eastern Hospital
name: Queen Elizabeth Hospital, Hong Kong
name: United Christian Hospital
name: Kwong Wah Hospital
name: Princess Margaret Hospital, Hong Kong
name: Tuen Mun Hospital
First posted: 2020-07-10
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

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.

Eligibility 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

Primary outcomes:
measure: Seroconversion during pregnancy - DSS1
timeFrame: At DSS1 (Around 11-13 weeks gestation)
measure: Seroconversion during pregnancy - At delivery
timeFrame: At Delivery
measure: Pregnancy loss
timeFrame: At pregnancy loss
measure: Pregnancy course and perinatal outcome
timeFrame: From date of recruited until the date of delivery
measure: Vertical transmission
timeFrame: At Newborn 0 hours of life, mother immediately after delivery
measure: Vertical transmission
timeFrame: At Newborn 7 days of life
measure: Vertical transmission
timeFrame: At Newborn 14 days of life
measure: Vertical transmission
timeFrame: At Newborn 6 months of life
measure: Vertical transmission
timeFrame: At Newborn 18 months of life
measure: 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.
timeFrame: through study completion, up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong, Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
city: Hong Kong
country: Hong Kong
facility: United Christian Hospital
city: Torrejón De Ardoz
country: Spain
facility: Hospital Universitario de Torrejón
state: Madrid
Study officials:
References: