The ’Big Baby Trial’
Research type
Research Study
Full title
Induction of labour for predicted macrosomia
IRAS ID
229163
Contact name
Siobhan Quenby
Contact email
Sponsor organisation
University Hospitals Coventry and Warwickshire NHS Trust
Duration of Study in the UK
3 years, 5 months, 30 days
Research summary
Difficulty in delivering the shoulders of a baby after the head has already come out can be a serious complication during birth. Most babies that get into such trouble are larger than average. It has been suggested that if we can predict by ultrasound scan in the last weeks of pregnancy which babies are large and at increased risk, then we could deliver them a week or so earlier and reduce the chance of such complications.\n However the available evidence is not clear, and can be interpreted in different ways. To know if delivering large babies earlier is the right thing to do for baby and mother an objective clinical trial is needed to see whether it is really of benefit. We propose to do this through a study of 4000 pregnancies where an ultrasound scan had suggested that the baby in the womb is larger than expected for the woman’s size, therefore potentially at risk of problems with delivery of the shoulders during birth.\n With the mother’s consent, she would be allocated at random into either an early induction of labour group, with the aim to start labour at 38 weeks, or a control group where care is as normal and onset labour is awaited to start naturally. We will then look at whether, as a result of earlier birth, there were fewer instances of complications such as difficulty with the delivery of the shoulders.\n The study will help decide what the safest method is to care for pregnancies where, because of the large size of the baby, complications may occur during labour.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
18/SW/0039
Date of REC Opinion
19 Mar 2018
REC opinion
Further Information Favourable Opinion