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

February 7, 2024 updated by: Chiu Yee Liona Poon, Chinese University of Hong Kong
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
          • Ka Wang CHEUNG, MBBS, MRCOG; FHKCOG; FHKAM
          • Phone Number: 2255 4267
          • Email: ckw028a@ha.org.hk
      • Hong Kong, Hong Kong
        • Recruiting
        • Princess Margaret Hospital
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Elizabeth Hospital
        • Contact:
          • Wei Ling Teresa MA, FRCOG, FHKAM
          • Phone Number: 3506 2246
          • Email: mawlt@ha.org.hk
        • Sub-Investigator:
          • Nga Yui, Florrie YU, MBChB, MRCOG, FHKAM (O&G)
        • Sub-Investigator:
          • Ngai Man CHAN, MBBS, MSc
      • Hong Kong, Hong Kong
        • Recruiting
        • Tuen Mun Hospital
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Kwong Wah Hospital
        • Contact:
          • Wing Cheong LEUNG, MBBS, MRCOG, FHKAM, FHKCOG
          • Phone Number: 3517 5053
          • Email: leungwc@ha.org.hk
      • Hong Kong, Hong Kong
        • Recruiting
        • Pamela Youde Nethersole Eastern Hospital
        • Contact:
          • Chung Nin LEE, MBBS, MMedSc, FRCOG, FHKCOG
          • Phone Number: 2595 6815
          • Email: lcnz01@ha.org.ha
      • Hong Kong, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong, Prince of Wales Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Annie SY HUI, MBBS, MRCOG, FHKCOG, FHKAM
        • Sub-Investigator:
          • Ada WT TSE, MBChB
      • Hong Kong, Hong Kong
        • Recruiting
        • United Christian Hospital
        • Contact:
          • Choi Wah KONG, MBChB, MRCOG, FHKAM, FHKCOG
          • Phone Number: 3949 3444
          • Email: kcw305@ha.org.hk
  • Spain
    • Madrid
      • Torrejón De Ardoz, Madrid, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion during pregnancy - DSS1
Time Frame: At DSS1 (Around 11-13 weeks gestation)
Mother
At DSS1 (Around 11-13 weeks gestation)
Seroconversion during pregnancy - At delivery
Time Frame: At Delivery
Mother
At Delivery
Pregnancy loss
Time Frame: At pregnancy loss
Mother (1st); Mother and abortus/stillborn baby(2nd)
At pregnancy loss
Pregnancy course and perinatal outcome
Time Frame: From date of recruited until the date of delivery
Mother and Baby
From date of recruited until the date of delivery
Vertical transmission
Time Frame: At Newborn 0 hours of life, mother immediately after delivery
Mother and Baby
At Newborn 0 hours of life, mother immediately after delivery
Vertical transmission
Time Frame: At Newborn 7 days of life
Mother and Baby
At Newborn 7 days of life
Vertical transmission
Time Frame: At Newborn 14 days of life
Mother and Baby
At Newborn 14 days of life
Vertical transmission
Time Frame: At Newborn 6 months of life
Mother and Baby
At Newborn 6 months of life
Vertical transmission
Time Frame: At Newborn 18 months of life
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.
Time Frame: through study completion, up to 2 years
Mother and Baby
through study completion, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Peking University First Hospital
Queen Elizabeth Hospital, Hong Kong
Queen Mary Hospital, Hong Kong
Tuen Mun Hospital
Kwong Wah Hospital
Pamela Youde Nethersole Eastern Hospital
Princess Margaret Hospital, Hong Kong
United Christian Hospital
Hospital Universitario de Torrejón

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 3, 2020

First Submitted That Met QC Criteria

July 9, 2020

First Posted (Actual)

July 10, 2020

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-MAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Non Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe