How NIHR is working to remove the barriers facing pre-term birth research

Professor Lucy Chappell, Chief Scientific Adviser at the Department of Health and Social Care (DHSC) and Chief Executive Officer of the NIHR, explains how the NIHR is working to remove the barriers facing pre-term birth research.

Sunday 17 November marked World Prematurity Day, a global movement to raise awareness of, and educate people about, premature birth and the impact it can have on families. Preterm birth – when a baby is born before 37 weeks of pregnancy – is the single biggest cause of neonatal mortality and morbidity in the UK. With around 8% of babies (estimated 48,000) born prematurely in England and Wales every year (based on Office for National Statistics data), this is a hugely important area, and one in which the NIHR invests and supports in a multitude of ways. 

In September, I gave evidence to the House of Lords’ Preterm Birth Committee alongside Baroness Merron, Minister for Mental Health and Women’s Health Strategy at DHSC, and Fiona Walshe, Director of Mental Health, Disabilities and Maternity at DHSC. During my evidence to the Committee, I set out 5 notable areas of challenge to research in this area:

• funding
• research capacity
• research participation
• ethical and regulatory frameworks
• uptake of evidence 

For each of these, there are tangible actions where the NIHR is taking collective action, together with other funders across the research cycle.   

Funding and scientific endeavour

Over the last 5 years, we have invested in 77 research awards through our research programmes, which, across their full duration, include £93m of funding. This includes studies focused on preventing or treating preterm birth in women, caring for babies born preterm, maternity services and staffing, the links between wider health and preterm birth, and support for families. 

We are working with the Medical Research Council (MRC) to ensure that, as government funders, we support the best scientific endeavours across our researchers. A notable example is the NIHR Efficacy and Mechanism Evaluation Programme, a partnership between MRC and NIHR, which commissioned the OPPTIMUM study to investigate the effectiveness of vaginal progesterone in reducing the risk of preterm birth. These findings subsequently informed the NICE guideline for preterm labour and birth [NG25].

Research capacity building

We launched a £50m Challenge funding call in 2024 with an explicit focus on maternity inequalities. This is an initiative designed to tackle the inequalities highlighted by the NHS England Core20PLUS5 initiative. The resulting consortium will develop and implement a research and capacity building programme to deliver a step change in the health of both women and their babies. This will build on a wider range of capacity building opportunities across NIHR, including those targeted at nurses, midwives and allied health professionals. 

Research participation

We are working to remove barriers to participation in research for women, and those impacted by preterm birth. In 2023/24, we recruited 237,523 participants to research within the reproductive health and childbirth speciality. This reflects more than a twofold increase from pre-pandemic recruitment numbers. To build on this, we can use innovative ways to address challenges in participation such as gaining women’s consent to take part in research during quick and unexpected preterm births.  

A two-stage consent pathway developed by the Cord Pilot trial is now recommended by the Royal College of Obstetricians and Gynaecologists for birth-related research trials and will support opportunities for women to participate in research relating to pregnancy and neonatal care. We continue to support initiatives such as the James Lind Alliance - Preterm birth to ensure that our research is shaped by and with public members.

Ethical and regulatory frameworks

To improve the frameworks that support the recruitment of participants to research studies, the NIHR is involved in the Medical Science Sex and Gender Equity (MESSAGE) project which seeks to co-develop best practice recommendations and a sex and gender policy framework for funders and regulators. This is part of the wider work that the NIHR has championed for many years, including through our Research Inclusion Strategy 2022-2027 and initiatives championed by the Health Research Authority. 

NIHR has now taken the step of making research inclusion a condition of funding, with all new research programmes to include costed research inclusion plans with researchers held to account for delivering on their plans. This is aligned with ongoing work by the UK medicines regulator, outlined in their Safer Medicines in Pregnancy and Breastfeeding Consortium initiative, that seeks to improve how pregnant and breastfeeding women make informed decisions about their healthcare.

Uptake of evidence for impact

We must ensure we continue to support a virtuous research cycle by identifying, using and improving our pathways to meaningful impact. For example, the NIHR Programme Grants for Applied Research funded a £1.9 million programme to improve the quality of care and health of very preterm babies. Improving parents’ experiences has been a key facet of this work and the team’s evaluation of trolleys in the Liverpool Women’s Hospital showed that life-saving care could be provided successfully at the bedside. Other UK maternity units are now using the trolley, helping them deliver more family-centred care for around 2,000 babies each year. The trolleys have also been adopted internationally, including hospitals in Norway, Italy and the USA.

Going further

There is of course more we can do. The Select Committee’s report recognises that ‘Research is an essential component of optimising care and outcomes for mothers at risk of preterm birth and babies who are born prematurely.’ It calls for ‘A greater focus on pregnancy and neonatal research is needed, alongside increased funding, to make progress in understanding the fundamental mechanisms of preterm labour, developing more effective interventions, and ensuring clinical guidance is implemented effectively.’ 

Pregnancy and neonatal research present a window of opportunity to influence outcomes for the woman and infants across the whole of their lives. We must actively and continually seek ways to go further, to build our understanding of the most effective, woman-centred ways to prevent preterm birth, to provide treatment and support for preterm babies and their families, and to ensure that we implement evidence optimally.