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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Recruiting
        • Hospital Universitario de Torrejón
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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