Examining COVID-19 effects during pregnancy and risks of transmission
Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)
This study looks at how COVID-19 affects pregnant women and their babies, including the chances of passing the virus from mother to child.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 10 sites (Beijing, Beijing and 9 other locations) |
| Trial ID | NCT04465474 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prevalence of SARS-CoV-2 seroconversion among pregnant women in Hong Kong and evaluate the impact of COVID-19 on maternal and perinatal outcomes. It will investigate the rates of infection in women experiencing miscarriage and stillbirth, track the pregnancy course of confirmed COVID-19 cases, and analyze the risk of vertical transmission of the virus. The study will involve collaboration among various medical specialists and will utilize both longitudinal and cross-sectional methodologies to gather comprehensive data. Additionally, it will explore the placental barrier and immune responses related to vertical transmission.
Who should consider this trial
Good fit: Ideal candidates include pregnant women attending Down syndrome screening or those presenting with miscarriage or stillbirth in Hong Kong and Spain.
Not a fit: Patients who are not pregnant or those who have not been affected by COVID-19 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the risks of COVID-19 during pregnancy, potentially improving maternal and fetal health outcomes.
How similar studies have performed: Previous studies have shown varying results regarding COVID-19's impact on pregnancy, but this study aims to systematically collect data, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing and 9 other locations
- Peking University First Hospital — Beijing, Beijing, China (Recruiting)
- Kwong Wah Hospital — Hong Kong, Hong Kong (Recruiting)
- Pamela Youde Nethersole Eastern Hospital — Hong Kong, Hong Kong (Recruiting)
- Princess Margaret Hospital — Hong Kong, Hong Kong (Recruiting)
- Queen Elizabeth Hospital — Hong Kong, Hong Kong (Recruiting)
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
- The Chinese University of Hong Kong, Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
- Tuen Mun Hospital — Hong Kong, Hong Kong (Recruiting)
- United Christian Hospital — Hong Kong, Hong Kong (Recruiting)
- Hospital Universitario de Torrejón — Torrejón De Ardoz, Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Liona POON
- Email: liona.poon@cuhk.edu.hk
- Phone: (852) 3505 2582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.