Cardiff University

Health and Care Research WalesCardiff University

Yes

6501-D23E-5781-82E3-79B9-6060

AIMS OF THIS WORK Using routine (already collected) data we will test if there is a difference in the rate of brain injury or death between the babies who are born by caesarean and those born vaginally, without additional intervention. We will use this to plan a future clinical trial to find out the best way to deliver premature babies. WHAT WE KNOW ALREADY Babies born very preterm (before 32 weeks of gestation) are at high risk of dying or developing brain injuries around birth. Some are born by caesarean section and these babies appear to have a better chance of surviving and escaping brain injury than those born vaginally. WHAT WE HOPE TO DISCOVER We think that a future randomised trial, where mode of birth is decided by chance, is the only way to really work out what the best way to deliver premature babies is. We can’t do such a trial yet because we don’t know enough about how to best design such a trial. We will get this knowledge using, already collected, routine data. First we will identify groups of babies born preterm, with similar relevant characteristics, some of whom are born by caesarean section and others by vaginal birth. In some of these pregnancies the doctors recommend, and the mothers appear to choose, one mode of delivery or another. We will then identify if their mode of birth is associated with a better or worse outcome . Second, we will then use the same data, together with a technique known as a “Emulated Target Trial ”, to work out if babies are more likely to survive without brain injury if we ran a randomised trial in different groups of women. From this we will identify how useful a trial may be and what the likely benefits of optimising the mode of birth of these very preterm infants could be. This will allow us to design the best, and most efficient, clinical trial in the future, to obtain the vital data we need to guide mothers to base their mode of birth decisions.

The most optimal route of birth of these babies continues to be debated, but the role of caesarean section (CS) as a protective measure against sIVH in very preterm babies has been proposed. A recent Cochrane systematic review and meta-analysis of interventional studies was unable to make recommendations as not enough women have been recruited into trials at preterm gestations, however observational studies have suggested benefit for CS in reducing neonatal mortality and morbidity in preterm infants. A recent NIHR funded project aimed to try and identify the areas where a clinical trial might be performed[10] but concluded that at present a trial would be practically challenging to perform. Underpinning this uncertainty is the lack of clear evidence of how effective CS may be and in whom it may be most beneficial. This project is the next step to help identify evidence behind the optimal perinatal management of preterm births; and aligns with a recent priority setting partnership.

01/10/2023

28/02/2025

02/04/2024

(e) processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

(j) processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

Not applicable

One-off

15/01/2025

Release

Data will be de-identified at source.