Global study to assess the effects of COVID-19 in pregnancy on mothers and babies launched | University of Oxford

Global study to assess the effects of COVID-19 in pregnancy on mothers and babies launched

24 April 2020

Researchers at the University of Oxford are today starting a large, international study to evaluate the effects of COVID-19 in pregnancy. The INTERCOVID study will provide women, families, health care providers and policy makers with high-quality evidence regarding the effects of COVID-19 in pregnancy on the health of the mother, fetus and newborn.

The information is needed quickly and at scale to optimise pregnancy care, reduce maternal anxiety, inform decision-making about the allocation of resources, and guide the process toward social adaptation. Although it is generally believed that pregnant women with COVID-19 are at similar risk to the general population, there is limited data available, principally from small studies without controls, which cannot answer fundamental questions relating to the effects of the disease on maternal and neonatal outcomes.

The researchers will be recruiting women who have been exposed and not-exposed to SARS-CoV-2 at any stage of pregnancy, and following them and their newborns until hospital discharge to quantify the risks associated with the exposure. Exposed pregnant women are defined as having:

a) laboratory confirmed COVID-19;
b) radiological findings suggestive of COVID-19;
c) symptoms compatible with COVID-19 according to a predefined list, or;
d) no symptoms, whilst in close interaction with a person(s) with confirmed COVID-19 infection (a proxy for asymptomatic cases, one of the main problems in controlling the pandemic).

For every exposed pregnant woman, two not-exposed pregnant women will be recruited as representative of the general population.

Professor José Villar of the University’s Nuffield Department of Women’s & Reproductive Health, (NDWRH) who is leading the research, said: ‘This large study benefits from the University having hosted, over the last 12 years, a network of researchers across the world who have participated in the INTERGROWTH-21st Project[1] which has produced new international standards for monitoring growth and development from early pregnancy to 2 years of age.
‘As a result, we have in place trained research staff and standardised data collection forms focused on outcomes, such as preterm birth and neonatal morbidity. All the work is done via an online data collection system that provide information almost in real-time. For the present study, we have simply expanded to include COVID-19, which explains why we are able to start immediately’.

Professor Aris Papageorghiou (NDWRH), who is jointly leading the research, said: ‘The response from colleagues around the world has been truly remarkable. Already over 60 medical institutions in 29 countries have agreed to participate, which means the study should have sufficient power to provide invaluable answers, in a short time period, regarding the risks to pregnant women who are exposed to SARS-CoV-2. However, we welcome additional institutions who would like to join this important study’.

Professor Stephen Kennedy (NDWRH), who is jointly leading the research, said: ‘The translational value of the INTERCOVID Study is that we will be collecting invaluable baseline outcome data, as recommended by the Pregnancy Research Ethics for Vaccines, Epidemics and New Technologies (PREVENT) Report[2] to inform risk-benefit analyses for future vaccine trials in pregnant women by providing “potential risk relationships between vaccination and adverse events”. Failure to obtain that information runs the risk of pregnant women being denied priority access to a new vaccine or therapy, as has occurred so many times in the past.’

For further information or interview requests, please contact: Gen Juillet, Media Relations Manager, University of Oxford, gen.juillet@admin.ox.ac.uk

Notes to editors

Nuffield Department of Women's & Reproductive Health (NDWRH)
The Nuffield Department of Women's & Reproductive Health at the University of Oxford encompasses multi-disciplinary research across four overarching themes; Cancer, Global Health, Maternal & Fetal Health and Reproductive Medicine & Genetics. It focuses on genetic studies, the dissection of molecular, biochemical and cellular mechanisms underlying normal and aberrant reproductive tissue function, clinical studies in women’s health and pregnancy, and growth and development across the first 1000 days of life. More information: https://www.wrh.ox.ac.uk/ @profskennedy

Oxford Maternal & Perinatal Health Institute (OMPHI)
The Oxford Maternal & Perinatal Health Institute (OMPHI), based at Green Templeton College, Oxford, works alongside the Nuffield Department of Women's & Reproductive Health, bringing together world experts to resolve priority maternal and perinatal health problems on a global scale. More information: https://www.wrh.ox.ac.uk/research/omphi

Oxford University Medical Sciences Division
Oxford University’s Medical Sciences Division is one of the largest biomedical research centres in Europe, with over 2,500 people involved in research and more than 2,800 students. The University is rated the best in the world for medicine and life sciences, and it is home to the UK’s top-ranked medical school. It has one of the largest clinical trial portfolios in the UK and great expertise in taking discoveries from the lab into the clinic. Partnerships with the local NHS Trusts enable patients to benefit from close links between medical research and health care delivery.

About Oxford University
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