PRECIOUS (PRETERM CAESAREAN/VAGINAL BIRTH & IVH/OUTCOMES) STUDY
Research type
Research Study
Full title
PRECIOUS (PRETERM CAESAREAN/VAGINAL BIRTH & IVH/OUTCOMES) STUDY: DOES MODE OF BIRTH REDUCE THE RISK OF DEATH OR BRAIN INJURY IN VERY PRETERM BABIES?
IRAS ID
331858
Contact name
David Odd
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
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. 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 do not know is if this is a real finding, or simply that babies who are less sick are delivered by caesarean. We also don’t know in which situations mothers, doctors, midwives and nurses are most uncertain around the right decision, and which groups of babies might benefit most to be included in a future trial.
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. We will use the 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.REC name
London - Queen Square Research Ethics Committee
REC reference
23/LO/0826
Date of REC Opinion
3 Oct 2023
REC opinion
Favourable Opinion