Aim

To nurture and support collaborative perinatal clinical research in order to conduct high impact multicentre clinical trials to improve health.

Leads: Professor Ed Juszczak and Dr Eleanor Mitchell

Professor Juszczak is Professor of Clinical Trials and Statistics in Medicine at Nottingham Clinical Trials Unit (NCTU) and previously Director of the Clinical Trials Unit at the University of Oxford's National Perinatal Epidemiology Unit, running a portfolio landmark neonatal and maternal clinical trials. These include: (i) TOBY evaluating Moderate Hypothermia to Treat Perinatal Asphyxia Encephalopathy and now standard of care across the world, (ii) CORONIS - evaluating caesarean section surgical techniques in 16,000 women in South America, Africa and South Asia, and (iii), the data-enabled INFANT trial which evaluated computerised interpretation of fetal heart rate during labour in 47,000 women. He currently leads a national perinatal platform trial development group.

Dr Mitchell is Associate Professor of Clinical Trials also at the NCTU. Her research interest and expertise is the design and conduct of randomised clinical trials, particularly in maternal and newborn health. She has led large multi-centre trials in the UK and is the Chair of a national network of clinical trial managers. She also leads an online parent and public involvement group for parents and expectant parents who are interested in perinatal research. She has also led newborn health studies in low-and-middle income countries, particularly in Kenya, and is a co-investigator on a $3.7million trial of oral iron for postnatal women in Nigeria.

Research Focus

Clinical trials are a cross-cutting methodology within the Centre for Perinatal Research linking with NCTU, a UKCRC-registered Clinical Trials Unit. With CePR, NCTU has a focus on conducting clinically important, high quality perinatal multi-centre randomised trials that improve health and wellbeing.

1. Conducting high quality randomised perinatal clinical trials. Working closely with clinicians, researchers and parents/families, we aim to conduct perinatal trials that change clinical practice, delivered to the highest standard.
   
   
2. Designing methodologically rich, efficient clinical trials. Efficient trials are needed to answer important research questions which are of high priority for clinicians, parents/families and the NHS. An example of this is the novel and exciting development of a perinatal platform trial which will facilitate randomisation of pregnant women and their babies during pregnancy, delivery and postnatally. To increase efficiency in future studies, it is also important to undertake embedded methodological studies within trials, and we aim to do this wherever possible.
   
   
3. Data-enabled clinical trials. To reduce waste within the health research eco-system, wherever possible our trials utilise routinely collected healthcare data, and we have increasing expertise in this area. An example of this is the NIHR-funded Group B Streptococcus (GBS) screening trial: www.gbs3trial.ac.uk investigating whether routinely screening for GBS during pregnancy reduces late-onset sepsis in newborns. The trial aims to collect routinely collected data from 340,000 women and pregnant women around the UK, to avoid burdening women and health services.
   
   
4. Global trials. The clinical trial theme cross-cuts geographical borders, with research being conducted nationally and internationally, in particular, in Low and Low Middle Income Countries (LMIC) where perinatal outcomes are often poor. When conducting research in these settings, we work with our local partners to ensure that the research objectives are aligned with the Sustainable Development Goals and targets.