On the 24th of April, researchers at the University of Oxford launched a global study to evaluate the effects of Covid-19 in pregnancy. The INTERCOVID study will be used to advise families, health care providers and policymakers with high-quality evidence regarding the effects of Covid-19 in maternal, fetal and neonatal outcomes.
INTERCOVID is a large, multi-national, prospective cohort study, coordinated by the INTERGROWTH-21st Team at the University of Oxford. Professor Jose Villar of the University’s Nuffield Department of Women’s & Reproductive Health (NDWRH), is leading the research.
It is believed that pregnant women with Covid-19 are at a similar risk to the general population, but there is currently limited data available to provide accurate evidence for this claim. The information is needed quickly in order to optimise the care available for women and their new-borns, reduce maternal anxiety, inform decision making about resource allocation, and guide the process toward social adaptation.
In the INTERCOVID study researchers will be recruiting women who are and are not exposed to Covid-19 at any stage of pregnancy, following mothers and new-borns until hospital discharge post-delivery.
The study began field preparations on 20 April 2020 and recruitment started immediately. Already, 62 medical institutions in 29 countries have agreed to participate.
It looks to collect invaluable baseline data as recommended by the Pregnancy Research Ethics for Vaccines, Epidemics and New Technologies (PREVENT) Report, in order to inform risk-benefit analyses for future vaccine trials in pregnant women by providing “potential risk relationships between vaccination and adverse events.”
Professor Stephen Kennedy (NDWRH), who is jointly leading the research, said that a failure to obtain this 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.”
The study defines “exposed” cases as pregnant women with any of the following: “laboratory-confirmed Covid-19; radiological pulmonary findings suggestive of Covid-19; maternal symptoms compatible with Covid-19; absence of symptoms, whilst in close interaction with a person(s) with confirmed Covid-19.” Each “exposed” case is compared with two “non-exposed” pregnant women, considered as a representative of the pregnancy population at each study site.
Professor Villar stated: “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. As a result, we have in place trained research staff and standardised data collection forms. All the work is done via an online data collection system that provides information almost in real-time.”
Professor Aris Papageorghiou (NDWRH), who is jointly leading the research, said that the “truly remarkable” response from international colleagues “means the study should have significant power to provide invaluable answers, in a short time period, regarding the risks to pregnant women who are exposed to SARS-CoV-2.”
The team has been contacted for comment.