A global registry of women affected by COVID-19 in pregnancy, understanding natural history to guide treatment and prevention

Lead Research Organisation: Imperial College London
Department Name: UNLISTED

Abstract

The current coronavirus outbreak (COVID-19) is growing in magnitude and will affect hundreds of pregnant women globally. MERS, SARS, and other coronovirus infectionscause more severe illness in pregnant women than non-pregnant women, with higher rates of deaths, pregnancy loss, premature births and small-for-dates babies.
There have been case reports of 18 women affected by COVID-19 in the later third of their pregnancy. There is a lack of information on the effect of COVID-19 at all stages of pregnancy e.g. early pregnancy and its effect on mothers’ and babies’ health before and after delivery.
This study will gather information from around the world of COVID-19 infection during pregnancy to inform treatment and how to prevent spread.
We will set up a database (register) of women affected by COVID-19 in pregnancy. Cases will be added by collaborators across Europe, China, Hong Kong and the USA. Information about the women, their pregnancies and babies will be entered by healthcare professionals into a secure web page.
Weekly reports from registery will be published online. This database of reported cases with detailed pregnancy outcomes will allow healthcare professionals, researchers and policy makers to plan prevention and treatments in this outbreak, and in the future.

Technical Summary

This COVID-19 Rapid Response award is jointly funded (50:50) between the Medical Research Council and the National Institute for Health Research. The figure displayed is the total award amount of the two funders combined, with each partner contributing equally towards the project.

BACKGROUND. In the current COVID outbreak, there are case reports with variable outcomes reported for 18 women affected by nCoV in the third trimester, 50% delivered pre-term but there were no reports of vertical transmission.
Therefore there are significant knowledgegaps regarding the impact of COVID-19 on mothers’ and babies’ health at all stages of pregnancy, including delivery and neonatal care, due to lack of primary data. SARS and MERS resulted in >25% case fatality in pregnant women, with worse effects in those infected in earlier pregnancy.
AIMS
To understand the natural history of COVID-19 in pregnancy, in order to guide treament and prevention during the outbreak.
DELIVERABLES
Registry: We will construct a registry of women affected by COVID-19 during pregnancy, detailing presenting symptoms, clinical course, key diagnostic testing modalities and pathology results, adverse pregnancy outcomes, including vertical transmission, perinatal and neonatal outcomes. Pseudonymised data will be entered by health professionals via a password-protected web portal; the database will be hosted in an established clinical trials unitwith a study co-ordinator, senior data manager and statistician.
We have a network of collaborators across Europe, China and USA to identify cases from these areas. Our senior project-partners in China and Hong Kong have expertise in women and children’s health and epidemiology and will facilitate case reporting in areas which have a high prevalence of COVID-19 .
This registry will be used to produce weekly online reports of aggregated, anonymised data during the outbreak to inform treatment and prevention during the outbreak, within the period of the grant. Data sharing (for pseudonymised individual participant data) will be made available for ethically approved research during and after the outbreak.

Publications

10 25 50
 
Description Advocate provision of SARS-COV-2 vaccine to all women in or planning pregnancy to ameliorate the increased risk of pre-term birth demonstrated by our study. We have sought to reassure the public that COVID-19 is not associated with an increase in risk of fetal growth restriction, stillbirth or neonatal death
Geographic Reach Multiple continents/international 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
 
Title Verbal consent and weekly Q&A sessions 
Description We have used verbal consent to avoid person to person spread of SARS-COV-2. We have held weekly study Q&A sessions to encourage recruitment and actively engaged on social media to encourage participation 
Type Of Material Improvements to research infrastructure 
Year Produced 2020 
Provided To Others? No  
Impact Reduced risk of infection Increased recruitment to the study 
 
Title PAN-COVID Dataset 
Description Full registry dataset will be made available via a persistent DOI on the Imperial Research Data Repository when the study is completed. 
Type Of Material Database/Collection of data 
Year Produced 2021 
Provided To Others? No  
Impact Increased knowledge of the effects of SARS-COV-2 infection in pregnancy and on pregnancy outcomes 
 
Description PAN-COVID study 
Organisation Cardiff University
Department Centre for Trials Research
Country United Kingdom 
Sector Academic/University 
PI Contribution Global collaboration,with 560 investigators, accross 187 centres in 16 countries to deliver study.
Collaborator Contribution They recruited participants and provided study data
Impact J Banerjee*, E Mullins*, J Townson et al. Pregnancy and Neonatal Outcomes in COVID-19: Study protocol for a global registry of women with suspected or confirmed SARS-CoV-2 infection in pregnancy and their neonates, understanding natural history to guide treatment and prevention. BMJ Open 2021;11:e041247. doi:10.1136/ bmjopen-2020-041247 E Mullins*, ML. Hudak*, J Banerjee, T Getzlaff, J Townson, K Barnette, R Playle, T Bourne, C Lees, Pregnancy and neonatal outcomes of COVID-19 - co-reporting of common outcomes from the PAN-COVID and AAP SONPM registry, Ultrasound Obstet Gynecol. 2021 Feb 23. E Mullins, Stuart Campbell lecture, Pregnancy through COVID and COVID through pregnancy, International Society of Ultrasound in Obstetrics and Gynaecology World Congress, October 2021
Start Year 2020
 
Description Media release of interim results 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact We engaged with Imperial and UKRI press offices to aid wider coverage of our interim data report.
We report our complete dataset at scientific meetings and publications and engage with mainstream and social media to disseminate this more widely.The publication had an Altmetric score of 142.
Year(s) Of Engagement Activity 2021
URL https://www.imperial.ac.uk/news/215533/covid-19-infection-pregnancy-linked-with-still/