COVIpreg: COVID-19 infection in pregnancy; A prospective cohort study of immunological response and long-term maternal morbidity. 

 

Background: 

COVID-19 infection, caused by a new virus, has caused a global crisis. Several expert groups, including the Royal College of Obstetricians and Gynaecologists have suggested pregnant women, who are usually young and healthy, are at increased risk of becoming unwell if they catch the virus. There is very limited information for healthcare professionals on how to best treat women who become unwell or what the short and long-term outcomes are for both mothers and babies.

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Aims: 

COVIpreg is an observational research study designed to answer the following about pregnant women diagnosed with COVID-19:

1. What are the factors that might make pregnant women more prone to severe infection? We are especially interested in the impact of ethnicity.

2. What happens to the immune system of pregnant women who are diagnosed with COVID-19?

3. Is there any immune response against the virus in the placenta?

4. What are the short and medium to long-term implications to women who develop COVID-19 infection in pregnancy, and what is the health of babies born to these women?

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To answer these questions, we are inviting all women who are admitted to the hospital, who are either pregnant or have recently given birth, and who have a suspected or confirmed diagnosis of Covid-19.

We will collect routine data about their health and demographic data, as well as on their pregnancy, birth and the course of their infection. Blood and urine samples will be collected for standard laboratory tests, as well as some extra blood to examine the immune response in more detail. For a proportion of women who consent to this, we will also analyse samples of the placenta and cord blood to check whether there is any immune response against the virus. After the infection has resolved and they have had their baby, participating women will be invited back to the hospital for 3 follow-up visits (up to 1 year after childbirth), to examine their lung function (by spirometry), collect data on their health and wellbeing, and collect another small blood sample for further analysis of their immune response.

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Study start: May 2020

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Study Duration: 24 Months

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Recruitment Target: 200

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Participating sites: Barts Health NHS Trust

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Funding: The study has received initial pump-prime funding from the February Foundation (UK Charity Reg
. 1113064)