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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)

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ClinicalTrials.gov Identifier: NCT04465474
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : July 21, 2020
Sponsor:
Collaborators:
Peking University First Hospital
Hospital Universitario de Torrejón
Queen Mary Hospital, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Queen Elizabeth Hospital, Hong Kong
United Christian Hospital
Kwong Wah Hospital
Princess Margaret Hospital, Hong Kong
Tuen Mun Hospital
Information provided by (Responsible Party):
Chiu Yee Liona Poon, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment
COVID-19 Other: Non Intervention

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 6 Months
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)
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Non Intervention
    It's an observational study, no intervention involves.


Primary Outcome Measures :
  1. Seroconversion during pregnancy - DSS1 [ Time Frame: At DSS1 (Around 11-13 weeks gestation) ]
    Mother

  2. Seroconversion during pregnancy - At delivery [ Time Frame: At Delivery ]
    Mother

  3. Pregnancy loss [ Time Frame: At pregnancy loss ]
    Mother (1st); Mother and abortus/stillborn baby(2nd)

  4. Pregnancy course and perinatal outcome [ Time Frame: From date of recruited until the date of delivery ]
    Mother and Baby

  5. Vertical transmission [ Time Frame: At Newborn 0 hours of life, mother immediately after delivery ]
    Mother and Baby

  6. Vertical transmission [ Time Frame: At Newborn 7 days of life ]
    Mother and Baby

  7. Vertical transmission [ Time Frame: At Newborn 14 days of life ]
    Mother and Baby

  8. Vertical transmission [ Time Frame: At Newborn 6 months of life ]
    Mother and Baby

  9. Vertical transmission [ Time Frame: At Newborn 18 months of life ]
    Mother and Baby

  10. 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


Biospecimen Retention:   Samples Without DNA

Biological samples Miscarriage: POC, maternal blood

Stillbirth: Maternal vaginal swab, amniotic fluid, amnion-chorion interface swab, placental tissue, fetal blood, fetal throat swab, maternal blood

Delivery: Maternal blood before delivery At or after delivery: amniotic fluid, cord blood, placental tissue, amnion-chorion interface swab, neonatal throat swab Breast milk from both breasts for the duration of hospitalization Newborn throat swab at 24 hours of life Newborn stool samples for the duration of hospitalization Infant throat swab and stool sample at 7 days of age Infant blood at 14 days, 6 months & 18 months of age



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465474


Contacts
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Contact: Liona POON (852) 3505 2582 liona.poon@cuhk.edu.hk
Contact: Equal L CHEN (852) 3505 1536 equalchen@cuhk.edu.hk

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China
Contact: Huixia YANG, MD, PhD       yanghuixia@bjmu.edu.cn   
Hong Kong
Kwong Wah Hospital Active, not recruiting
Hong Kong, Hong Kong
Pamela Youde Nethersole Eastern Hospital Recruiting
Hong Kong, Hong Kong
Contact: Chung Nin LEE, MBBS, MMedSc, FRCOG, FHKCOG    2595 6815    lcnz01@ha.org.ha   
Princess Margaret Hospital Active, not recruiting
Hong Kong, Hong Kong
Queen Elizabeth Hospital Recruiting
Hong Kong, Hong Kong
Contact: Wei Ling Teresa MA, FRCOG, FHKAM    3506 2246    mawlt@ha.org.hk   
Sub-Investigator: Nga Yui, Florrie YU, MBChB, MRCOG, FHKAM (O&G)         
Sub-Investigator: Ngai Man CHAN, MBBS, MSc         
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Ka Wang CHEUNG, MBBS, MRCOG; FHKCOG; FHKAM    2255 4267    ckw028a@ha.org.hk   
The Chinese University of Hong Kong, Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Liona Chiu Yee Poon, MBBS, MRCOG, MD    (852) 3505 2582    liona.poon@cuhk.edu.hk   
Contact: Equal L CHEN    (852) 3505 1536    equalchen@cuhk.edu.hk   
Sub-Investigator: Annie SY HUI, MBBS, MRCOG, FHKCOG, FHKAM         
Sub-Investigator: Ada WT TSE, MBChB         
Tuen Mun Hospital Active, not recruiting
Hong Kong, Hong Kong
United Christian Hospital Recruiting
Hong Kong, Hong Kong
Contact: Choi Wah KONG, MBChB, MRCOG, FHKAM, FHKCOG    3949 3444    kcw305@ha.org.hk   
Spain
Hospital Universitario de Torrejón Recruiting
Torrejón De Ardoz, Madrid, Spain
Contact: Maria del Mar GIL, PhD       mariadelmar.gil@ufv.es   
Sponsors and Collaborators
Chinese University of Hong Kong
Peking University First Hospital
Hospital Universitario de Torrejón
Queen Mary Hospital, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Queen Elizabeth Hospital, Hong Kong
United Christian Hospital
Kwong Wah Hospital
Princess Margaret Hospital, Hong Kong
Tuen Mun Hospital
  Study Documents (Full-Text)

Documents provided by Chiu Yee Liona Poon, Chinese University of Hong Kong:
Study Protocol  [PDF] July 2, 2020

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Responsible Party: Chiu Yee Liona Poon, Prof Poon, Chiu Yee Liona, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04465474    
Other Study ID Numbers: COVID-MAP
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chiu Yee Liona Poon, Chinese University of Hong Kong:
pregnancy
vertical transmission
pregnancy loss
ACE2 TMPRSS2
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases