Researchers at the University of Oxford are 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, foetus 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, 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 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.’