Induction of labour for predicted macrosomia: the Big Baby trial

ISRCTN	ISRCTN18229892
DOI	https://doi.org/10.1186/ISRCTN18229892
Integrated Research Application System (IRAS)	229163
Central Portfolio Management System (CPMS)	36723
National Institute for Health and Care Research (NIHR)	16/77/02
Sponsor	University Hospitals Coventry and Warwickshire NHS Trust
Funder	National Institute for Health and Care Research

Submission date: 04/04/2018
Registration date: 12/04/2018
Last edited: 05/03/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Difficulty in delivering the shoulders of a baby after the head has been delivered 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. However, the available evidence is not clear, and can be interpreted in different ways. The aim of this study is to find out whether delivering large babies earlier is the right thing to do for baby and mother.

Who can participate?
Pregnant women aged 18 years or over where an ultrasound scan suggests 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

What does the study involve?
Participants are randomly allocated to either an early induction of labour, with the aim to start labour at 38 weeks, or a control group where care is as normal and labour is left to start naturally. The study looks at whether, as a result of earlier birth, there are fewer instances of complications such as difficulty with the delivery of the shoulders.

What are the possible benefits and risks of participating?
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.

Where is the study run from?
Warwick Clinical Trials Unit (UK)

When is the study starting and how long is it expected to run for?
January 2018 to May 2023

Who is funding the study?
National Institute for Health Research - HTA (UK)

Who is the main contact?
Amy Arnold, BigBaby@warwick.ac.uk, Bigbaby2Up@warwick.ac.uk

Contact information

Ms Kimberley Stewart
Public

Warwick Clinical Trials Unit
Warwick Medical School
Gibbet Hill Campus
University of Warwick
Coventry
CV4 7AL
United Kingdom

Phone	+44 (0)24 76 151825
Email	Bigbaby@warwick.ac.uk

Ms Kimberley Stewart
Public

Warwick Clinical Trials Unit
Warwick Medical School
Gibbet Hill Campus
University of Warwick
Coventry
CV4 7AL
United Kingdom

Phone	+44 (0)24 76 151825
Email	Bigbaby2Up@warwick.ac.uk

Ms Siobhan Quenby
Scientific

Clinical Sciences Research Laboratories
University Hospitals Coventry and Warwickshire
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

ORCID ID	0000-0003-3221-5471
Phone	+44 (0)2476 964000
Email	s.quenby@warwick.ac.uk

Study information

Primary study design	Interventional
Study design	Randomized; Both; Design type: Treatment, Other
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Induction of labour for predicted macrosomia: the Big Baby trial
Study acronym	Big Baby
Study objectives	Difficulty in delivering the shoulders of a baby after the head has been delivered 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. 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. The trialists 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. 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.
Ethics approval(s)	South West-Exeter Research Ethics Committee, 19/03/2018, ref: 18/SW/0039
Health condition(s) or problem(s) studied	Maternal care for suspected macrosomia
Intervention	Current interventions as of 29/06/2023: Big Baby With the mother’s consent, she would be allocated at random (telephone or computer-based randomisation) 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. The trialists 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. Follow-up is 6 months. Big Baby 2Up As the Big Baby Trial was getting underway, evidence emerged linking reduced cognitive, reading and language skills and slightly increased learning problems in babies born one or two weeks from full term, but it is not known whether this effect is due to those born small for gestation or also applies to big babies in the same way. In this sub-study, we will assess the cognitive and language function of babies born to women participating in The Big Baby Trial when they reach 24 months of age. This will be assessed via the PARCA-R (Parent Report of Children’s Abilities-Revised) questionnaire (https://www2.le.ac.uk/partnership/parca-r/parca-r-resources). Pregnant women, their partners, midwives and obstetricians must have evidence-based information to be able to discuss and make informed decisions about the timing of birth if their baby is predicted to be above the 90th centile on the fetal growth chart and balance the risk of stillbirth, shoulder dystocia, maternal and neonatal morbidity, and babies longer-term cognitive function. Primary research question In babies with suspected macrosomia antenatally, does near-term delivery affect non-verbal cognition and language development, as measured by the Parent Report of Children’s Ability-Revised (PARCA-R), at 24 months? Secondary research questions 1. In infants with suspected macrosomia does induction at 38+0 - 38+4 weeks, when compared to expectant management, affect cognitive function (non-verbal cognition; language development) at 24 months? 2. In babies with suspected macrosomia does gestational age at the time of birth, weight centile, mode of delivery (normal vaginal delivery, assisted delivery, caesarean section (elective / emergency)) and exclusive breastfeeding predict cognitive function at 24 months? 3. What are the costs and health consequences of near-term delivery in macrosomic babies? Previous interventions: With the mother’s consent, she would be allocated at random (telephone or computer-based randomisation) 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. The trialists 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. Follow-up is 6 months.
Intervention type	Other
Primary outcome measure(s)	Current primary outcome measure as of 29/06/2023: Big Baby Incidence of shoulder dystocia, definition by the Royal College of Obstetricians and Gynaecologists as, ‘a vaginalcephalic delivery that requires additional obstetric manoeuvres to deliver the fetus after the head has delivered and gentle traction has failed’. Shoulder dystocia will be confirmed by a notes review, undertaken by an independent expert panel; data on management of shoulder dystocia and its potential complications are an important performance metric for maternity units and will be recorded reliably in the notes; Timepoint(s): End of the study Big Baby 2Up Non-verbal cognition and language development measured using the Parent Report of Children’s Ability-Revised (PARCA-R) at 24 months Previous primary outcome measure: Incidence of shoulder dystocia, definition by the Royal College of Obstetricians and Gynaecologists as, ‘a vaginalcephalic delivery that requires additional obstetric manoeuvres to deliver the fetus after the head has delivered and gentle traction has failed’. Shoulder dystocia will be confirmed by a notes review, undertaken by an independent expert panel; data on management of shoulder dystocia and its potential complications are an important performance metric for maternity units and will be recorded reliably in the notes; Timepoint(s): End of the study
Key secondary outcome measure(s)	Current secondary outcome measure as of 29/06/2023: Big Baby Fetal outcomes: Intrapartum: 1. Time recorded between delivery of the head and delivery of the body 2. Time in labour ward 3. Time from commencement of active second stage of labour until fetal expulsion 4. Stillbirths Neonatal: 1. Neonatal death 2. Birth weight 3. Gestation at birth 4. Apgar score at five minutes 5. Fractures 6. Brachial plexus injuries 7. Admission to the neonatal unit/duration of stay 8. Hypoxic-ischaemic encephalopathy 9. Use of phototherapy 10. Respiratory morbidity 11. Hypoglycaemia Infants: 1. Proportion under specialist medical care at 2 months for a problem related to intra-partum experience 2. Maternal report of infant health concerns at 6 months 3. In hospital health care costs Maternal outcomes: Intrapartum: 1. Duration of hospital stay prior to delivery 2. Mode of delivery 3. Perineal tear (episiotomy or spontaneous 1st to 4th degree perineal tear) 4. Vaginal/cervical laceration or tear 5. Primary postpartum haemorrhage (≥1000ml) 6. Retained placenta 7. Death Post-partum: 1. Sepsis 2. Fever (>38.0°c) 3. Duration of hospital stay after delivery 4. Uptake of breastfeeding 5. Hospital readmission within 30 days of postnatal inpatient discharge Longer term outcomes: Women’s physical and psychological health and satisfaction with delivery: 1. Experience; six simple questions (SSQ) at 2 months 2. Duration of exclusive breastfeeding at 2 and 6 months 3. Health-related quality of life (EQ-5D-5L) at baseline, 2 and 6 months (appropriate licences to allow reproduction of these questionnaires will be obtained) 4. Edinburgh post-natal depression scale at baseline, 2 and 6 months 5. Impact of Events Scale at 2 months 7. Post-partum bonding questionnaire at 2 months 8. Maternal report of infant health at 2 and 6 months 9. Urinary incontinence ICIQ-UI short form assessed at baseline, 2 and 6 months 10. Sexual function at baseline and 6 months 11. Maternal and infant death at 6 months from HES-ONS linked mortality data. Obtain if the 6 month follow-up is not completed 12. Participant health resource used for economic analysis for mother and baby at 2 and 6 months Composite outcomes: 1. Intra-partum birth injury: one or both of fractures or brachial plexus injury 2. Prematurity associated problems: one or both of use of phototherapy or respiratory support 3. Maternal intra-partum complications: one or more of 3rd or 4th degree perineal tear, vaginal/cervical laceration or tear, or primary postpartum haemorrhage Big Baby 2Up 1. Cognitive function (non-verbal cognition; language development) measured using the Parent Report of Children’s Ability-Revised (PARCA-R) at 24 months 2. Gestational age at the time of birth, weight centile, mode of delivery (normal vaginal delivery, assisted delivery, caesarean section (elective / emergency)) and exclusive breastfeeding as documented in patient medical records at 24 months 3. Cost and health consequences of near-term delivery will be measured by adapting our standardised resource use questionnaires which we have used successfully in our other trials at 24 months. Previous secondary outcome measure: Fetal outcomes: Intrapartum: 1. Time recorded between delivery of the head and delivery of the body 2. Time in labour ward 3. Time from commencement of active second stage of labour until fetal expulsion 4. Stillbirths Neonatal: 1. Neonatal death 2. Birth weight 3. Gestation at birth 4. Apgar score at five minutes 5. Fractures 6. Brachial plexus injuries 7. Admission to the neonatal unit/duration of stay 8. Hypoxic-ischaemic encephalopathy 9. Use of phototherapy 10. Respiratory morbidity 11. Hypoglycaemia Infants: 1. Proportion under specialist medical care at 2 months for a problem related to intra-partum experience 2. Maternal report of infant health concerns at 6 months 3. In hospital health care costs Maternal outcomes: Intrapartum: 1. Duration of hospital stay prior to delivery 2. Mode of delivery 3. Perineal tear (episiotomy or spontaneous 1st to 4th degree perineal tear) 4. Vaginal/cervical laceration or tear 5. Primary postpartum haemorrhage (≥1000ml) 6. Retained placenta 7. Death Post-partum: 1. Sepsis 2. Fever (>38.0°c) 3. Duration of hospital stay after delivery 4. Uptake of breastfeeding 5. Hospital readmission within 30 days of postnatal inpatient discharge Longer term outcomes: Women’s physical and psychological health and satisfaction with delivery: 1. Experience; six simple questions (SSQ) at 2 months 2. Duration of exclusive breastfeeding at 2 and 6 months 3. Health-related quality of life (EQ-5D-5L) at baseline, 2 and 6 months (appropriate licences to allow reproduction of these questionnaires will be obtained) 4. Edinburgh post-natal depression scale at baseline, 2 and 6 months 5. Impact of Events Scale at 2 months 7. Post-partum bonding questionnaire at 2 months 8. Maternal report of infant health at 2 and 6 months 9. Urinary incontinence ICIQ-UI short form assessed at baseline, 2 and 6 months 10. Sexual function at baseline and 6 months 11. Maternal and infant death at 6 months from HES-ONS linked mortality data. Obtain if the 6 month follow-up is not completed 12. Participant health resource used for economic analysis for mother and baby at 2 and 6 months Composite outcomes: 1. Intra-partum birth injury: one or both of fractures or brachial plexus injury 2. Prematurity associated problems: one or both of use of phototherapy or respiratory support 3. Maternal intra-partum complications: one or more of 3rd or 4th degree perineal tear, vaginal/cervical laceration or tear, or primary postpartum haemorrhage
Completion date	26/05/2023

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	Female
Target sample size at registration	4000
Total final enrolment	2895
Key inclusion criteria	1. Women aged 18 years or over 2. Women with a fetus above 90th estimated fetal weight centile on ultrasound scan at 35+0 to 38+0 weeks gestation 3. Women with a cephalic presentation
Key exclusion criteria	Current exclusion criteria as of 14/11/2018: 1. Multiple pregnancy 2. Breech pregnancy or transverse lie presentation 3. Induction of labour contra-indicated 4. Fetus with known serious abnormality 5. Home birth or elective caesarean section already planned 6. Caesarean section or induction indicated due to health conditions such as cardiac disease or hypertensive disorders 7. Women taking medications and insulin therapy for diabetes or gestational diabetes; women with these conditions who are not taking medication are eligible 8. Current diagnosis of major psychiatric disorder which requires antipsychotic medication 9. Women unable to give informed consent e.g. learning or communication difficulties that prevent understanding of the information provided 10. Prisoners 11. Previous stillbirth 12. Previous neonatal death ≤28 days 13. Current intrauterine fetal death Previous exclusion criteria: 1. Multiple pregnancy 2. Breech pregnancy or transverse lie presentation 3. Induction of labour contra-indicated 4. Fetus with known serious abnormality 5. Home birth or elective caesarean section already planned 6. Caesarean section or induction indicated due to health conditions such as cardiac disease, epilepsy, or hypertensive disorders 7. Women taking medications and insulin therapy for diabetes or gestational diabetes; women with these conditions who are not taking medication are eligible 8. Current diagnosis of major psychiatric disorder which requires antipsychotic medication 9. Women unable to give informed consent e.g. learning or communication difficulties that prevent understanding of the information provided 10. Prisoners 11. Previous stillbirth 12. Previous neonatal death
Date of first enrolment	01/05/2018
Date of final enrolment	25/11/2022

Locations

Countries of recruitment

United Kingdom
England
Northern Ireland
Scotland
Wales

Study participating centres

University Hospital Coventry and Warwickshire

Clifford Bridge Road
Coventry
CV2 2DX
England

Shrewsbury and Telford Hospital NHS Trust

Mytton Oak Road
Shrewsbury
SY3 8XQ
England

South Warwickshire NHS Foundation Trust

Lakin Road
Warwick
CV34 5BW
England

Liverpool Women’s Hospital NHS Foundation Trust

Crown St
Liverpool
L8 7SS
England

Heartland of England NHS Foundation Trust

Bordesley Green East
Birmingham
B9 5SS
England

George Eliot Hospital NHS Trust

College Street
Nuneaton
CV10 7DJ
England

The Pennine Acute Hospitals NHS Trust

Rochdale Road
Oldham
OL1 2JH
England

Royal Bolton Hospital

Bolton NHS Foundation Trust
Minerva Road
Farnworth
Bolton
BL4 0JR
England

Calderdale Royal Hospital

Woman’s Service
Huddersfield Road
Halifax
HX3 0PW
England

Huddersfield Royal Infirmary

Woman’s Service
Acre Street
Huddersfield
HD3 3EA
England

Darlington Memorial Hospital

Hollyhurst Road
Darlington
DL3 6HX
England

University Hospital of North Durham

North Road
Durham
DH1 5TW
England

Burnley General Hospital

Casterton Avenue
Burnley
BB10 2PQ
England

Royal Blackburn Hospital

Haslingden Road
Blackburn
BB2 3HH
England

Burnley General Hospital

Woman’s Health - BGH
Casterton Avenue
Burnley
BB10 2PQ
England

Frimley Park Hospital

Portsmouth Road
Frimley
GU16 7UJ
England

Wexham Park Hospital

Wexham
Slough
SL2 4HL
England

Queen Charlotte’s Hospital

Du Cane Road
London
W12 0HS
England

Leeds General Infirmary

Great George Street
Leeds
LS1 3EX
England

St James’s Hospital

Beckett Street
Leeds
LS9 7TF
England

St Mary’s Hospital

Oxford Road
Manchester
M13 9WL
England

Leighton Hospital

Leighton
Crewe
CW1 4QJ
England

Norfolk and Norwich University Hospital

Colney Lane
Colney
Norwich
NR4 7UY
England

University Hospital of North Tees

UH North Tees Obstetrics and Gynaecology
Hardwick Road
Stockton-On-Tees
Cleveland
TS19 8PE
England

Hinchingbrooke Hospital

Hinchingbrooke Park
Huntingdon
PE29 6NT
England

Peterborough City Hospital

Edith Cavell Campus
Bretton Gate
Bretton
Peterborough
PE3 9GZ
England

Salisbury District Hospital

Odstock Road
Salisbury
SP2 8BJ
England

Kings Mill Hospital

Mansfield Road
Sutton-In-Ashfield
NG17 4JL
England

Whiston Hospital

Warrington Road
Prescot
L35 5DR
England

Worcestershire Royal Hospital

Charles Hastings Way
Worcester
WR5 1DD
England

Ormskirk & District General Hospital

Wigan Road
Ormskirk
L39 2AZ
England

The Whittington Hospital

Highgate Hill
London
N19 5NF
England

Chelsea & Westminster Hospital

369 Fulham Road
London
SW10 9NH
England

West Middlesex University Hospital

Twickenham Road
Isleworth
TW7 6AF
England

Queen Elizabeth the Queen Mother Hospital

St Peter's Road
Margate
CT9 4AN
England

The Maidstone Hospital

Hermitage Lane
Maidstone
ME16 9QQ
England

Tunbridge Wells Hospital

The Tunbridge Wells Hospital
Tonbridge Road
Pembury
Tunbridge Wells
TN2 4QJ
England

Sunderland Royal Hospital

Kayll Road
Sunderland
SR4 7TP
England

South Tyneside District Hospital

Harton Lane
South Shields
NE34 0PL
England

Singleton Hospital

Sketty Lane
Sketty
Swansea
SA2 8QA
Wales

Neath Port Talbot Hospital

Baglan Way
Port Talbot
SA12 7BX
Wales

Royal Gwent Hospital

Cardiff Road
Newport
NP20 2UB
Wales

Nevill Hall Hospital

Brecon Road
Abergavenny
NP7 7EG
Wales

York Hospital

Wigginton Road
York
YO31 8HE
England

Scarborough General Hospital

Woodlands Drive
Scarborough
YO12 6QL
England

Lister Hospital

Coreys Mill Lane
Stevenage
SG1 4AB
England

Luton & Dunstable Hospital

Lewsey Road
Luton
LU4 0DZ
England

Victoria Hospital (blackpool)

Whinney Heys Road
Blackpool
FY3 8NR
England

Hull Royal Infirmary

Anlaby Road
Hull
HU3 2JZ
England

Poole General Hospital

St Mary's Carpark
Longfleet Road
Poole
BH15 2JB
England

Musgrove Park Hospital (taunton)

Musgrove Park Hospital
Taunton
TA1 5DA
England

St Richard's Hospital

Spitalfield Lane
Chichester
PO19 6SE
England

Worthing Hospital

Lyndhurst Road
Worthing
BN11 2DH
England

Burton General Hospital

Burton Hospitals Unit
New Street
Burton -on-trent
DE14 3QH
England

Wrexham Maelor Hospital

Croesnewydd Road
Wrexham Technology Park
Wrexham
LL13 7TD
Wales

Ysbyty Glan Clwyd

Glan Clwyd Hospital
Rhuddlan Road
Bodelwyddan
Rhyl
LL18 5UJ
Wales

Ysbyty Gwynedd Hospital (yg NHS Trust)

Ysbyty Gwynedd
Penrhosgarnedd
Bangor
LL57 2PW
Wales

Pinderfields General Hospital

Aberford Road
Wakefield
WF1 4DG
England

Cumberland Infirmary

Newtown Road
Carlisle
CA2 7HY
England

West Cumberland Hospital

Homewood
Hensingham
Whitehaven
CA28 8JG
England

Warrington Hospital (site)

Warrington Hospital
Lovely Lane
Warrington
WA5 1QG
England

Basildon University Hospital

Nethermayne
Basildon
SS16 5NL
England

Queen Elizabeth Hospital

Sheriff Hill
Gateshead
NE9 6SX
England

Furness General Hospital

Dalton Lane
Barrow-in-furness
LA14 4LF
England

Royal Albert Edward Infirmary

Wigan Lane
Wigan
WN1 2NN
England

University Hospital Crosshouse

Kilmarnock Road
Kilmarnock
KA2 0BE
Scotland

Wishaw General Hospital

50 Netherton Street
Wishaw
ML2 0DP
Scotland

Chesterfield Royal Hospital

Chesterfield Road
Calow
Chesterfield
S44 5BL
England

St Marys Hospital

Parkhurst Road
Newport
PO30 5TG
England

Birmingham Women's Hospital

Mindelsohn Way
Edgbaston
Birmingham
B15 2TG
England

Barnet Hospital

Wellhouse Lane
Barnet
EN5 3DJ
England

The Royal Free Hospital

Pond Street
London
NW3 2QG
England

East Surrey Hospital

Canada Avenue
Redhill
RH1 5RH
England

Yeovil District Hospital

Higher Kingston
Yeovil
BA21 4AT
England

Royal Preston Hospital

Sharoe Green Lane North
Fulwood
Preston
PR2 4BR
England

Birmingham City Hospital

Dudley Road
Birmingham
B18 7QH
England

Arrowe Park Hospital

Arrowe Park Road
Wirral
CH49 5PE
England

Hereford County Hospital

Union Walk
Hereford
HR1 2ER
England

University Hospital of Wales

Heath Park
Cardiff
CF14 4XW
Wales

James Cook University Hospital

Marton Road
Middlesbrough
TS4 3BW
England

Aberdeen Maternity Hospital

Foresterhill
Aberdeen
AB25 2ZL
Scotland

Stepping Hill Hospital

Stockport NHS Foundation Trust
Poplar Grove
Hazel Grove
Stockport
SK2 7JE
England

Ipswich Hospital

Heath Road
Ipswich
IP4 5PD
England

Epsom Hospital

Epsom General Hospital
Dorking Road
Epsom
KT18 7EG
England

St Helier Hospital

Wrythe Lane
Carshalton
SM5 1AA
England

Scunthorpe General Hospital

Cliff Gardens
Scunthorpe
DN15 7BH
England

Goole & District Hospital

Woodland Avenue
Goole
DN14 6RX
England

Countess of Chester Hospital

Countess of Chester Health Park
Liverpool Road
Chester
CH2 1UL
England

Milton Keynes General Hospital

Milton Keynes Hospital
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
England

Dorset County Hospital

Williams Avenue
Dorchester
DT1 2JY
England

Kettering General Hospital

Rothwell Road
Kettering
NN16 8UZ
England

North Tyneside General Hospital

Rake Lane
North Shields
NE29 8NH
England

Northumbria Specialist Emergency Care Hospital

Northumbria Way
Cramlington
NE23 6NZ
England

Wansbeck Hospital

Woodhorn Lane
Ashington
NE63 9JJ
England

James Paget University Hospital

Lowestoft Road
Gorleston
Great Yarmouth
NR31 6LA
England

The Queen Elizabeth Hospital

Gayton Road
King's Lynn
PE30 4ET
England

Manor Hospital

Moat Road
Walsall
WS2 9PS
England

Prince Charles Hospital

Merthyr/cynon Unit
Merthyr Tydfil
CF47 9DT
Wales

Princess of Wales Hospital

Coity Road
Bridgend
Bridgend County Borough
CF31 1RQ
Wales

Watford General Hospital

60 Vicarage Road
Watford
WD18 0HB
England

West Suffolk Hospital

Hardwick Lane
Bury St. Edmunds
IP33 2QZ
England

Royal Cornwall Hospital (treliske)

Treliske
Truro
TR1 3LJ
England

Whipps Cross University Hospital

Whipps Cross Road
Leytonstone
London
E11 1NR
England

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from the Warwick Clinical Trials Unit Data Sharing Committee and Chief Investigators. Requests for data sharing are welcomed from universities, NHS organisations, or companies involved in health and care research, both in the UK and abroad. To ensure the highest standards of data protection and research integrity, the following access criteria apply: 1. Application process: researchers must submit a formal request to the Warwick Clinical Trials Unit (WCTU) Data Sharing Committee via WCTUDataAccess@warwick.ac.uk. 2. Approvals: all requests require approval from the Chief Investigators and the WCTU Data Sharing Committee, as well as evidence of relevant ethical approval for the proposed work. 3. Scope of analysis: data will only be shared for analyses that align with the UK Policy Framework for Health and Social Care Research and serve the public interest. 4. Mechanism: following approval and the execution of a formal Data Sharing Agreement, datasets will be shared via a secure platform implementing appropriate technical and organisational safeguards. Ethical and legal considerations: While participants’ consent was obtained for the original study, it did not include permission to share confidential patient data. Consequently, all shared data will be fully anonymised. No participant-identifiable information will be released, and the data will not be combined with other sources in a way that could identify individuals. The information is shared solely for health and care research purposes and will have no impact on participants' personal care or future services, such as insurance. Organisations and researchers are strictly prohibited from using this data to contact participants.

Individual participant data (IPD) Intention to share

Yes

IPD sharing plan

The datasets generated during and/or analysed during the current study are/will be available upon request from the Warwick Clinical Trials Unit Data Sharing Committee and Chief Investigators.

Requests for data sharing are welcomed from universities, NHS organisations, or companies involved in health and care research, both in the UK and abroad. To ensure the highest standards of data protection and research integrity, the following access criteria apply:
1. Application process: researchers must submit a formal request to the Warwick Clinical Trials Unit (WCTU) Data Sharing Committee via WCTUDataAccess@warwick.ac.uk.
2. Approvals: all requests require approval from the Chief Investigators and the WCTU Data Sharing Committee, as well as evidence of relevant ethical approval for the proposed work.
3. Scope of analysis: data will only be shared for analyses that align with the UK Policy Framework for Health and Social Care Research and serve the public interest.
4. Mechanism: following approval and the execution of a formal Data Sharing Agreement, datasets will be shared via a secure platform implementing appropriate technical and organisational safeguards.

Ethical and legal considerations:
While participants’ consent was obtained for the original study, it did not include permission to share confidential patient data. Consequently, all shared data will be fully anonymised. No participant-identifiable information will be released, and the data will not be combined with other sources in a way that could identify individuals. The information is shared solely for health and care research purposes and will have no impact on participants' personal care or future services, such as insurance. Organisations and researchers are strictly prohibited from using this data to contact participants.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Cost-effectiveness	01/05/2025	02/05/2025	Yes	No
Results article	Primary results publication	01/05/2025	08/05/2025	Yes	No
Protocol article		11/11/2022	14/11/2022	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 15.1	05/11/2024	09/05/2025	No	No
Statistical Analysis Plan	version 4.0	10/02/2023	23/06/2023	No	No
Statistical Analysis Plan	Health Economics Analysis Plan version 1.0	05/12/2022	09/05/2025	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN18229892_SAP_v4.0_10February2023.pdf: Statistical Analysis Plan
ISRCTN18229892_Protocol_v15.1_05Nov2024.pdf: Protocol file
ISRCTN18229892_HEAP_v1.0_05Dec2022.pdf: Health Economics Analysis Plan

Editorial Notes

05/03/2026: IPD sharing plan added.
19/02/2026: Contact details updated. Northern Ireland was added to the countries of recruitment.
09/07/2025: NIHR grant code added to the secondary identifying numbers, and NIHR was linked as a funder.
09/05/2025: Protocol version 15.1 (not peer reviewed) and health economics analysis plan version 1.0 uploaded.
08/05/2025: Publication reference added.
02/05/2025: Publication reference added.
10/01/2025: The intention to publish date was changed from 31/12/2024 to 31/03/2025.
30/04/2024: The intention to publish date was changed from 30/04/2024 to 31/12/2024.
22/01/2024: Contact details updated.
19/01/2024: The intention to publish date was changed from 31/01/2024 to 30/04/2024.
29/06/2023: The following changes have been made:
1. The interventions were changed.
2. The primary outcome measure was changed.
3. The secondary outcome measure was changed.
4. The scientific contact was changed.
5. The plain English summary was updated to reflect these changes.
23/06/2023: Statistical analysis plan uploaded.
30/05/2023: The following changes have been made:
1. The overall study end date has been changed from 30/07/2023 to 26/05/2023 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 30/12/2023 to 31/01/2024.
19/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2022 to 25/11/2022.
2. The overall end date was changed from 30/04/2023 to 30/07/2023.
3. The plain English summary was updated to reflect these changes.
4. The total final enrolment was added.
5. The IRAS number was added.
6. The trial participating centres Royal Cornwall Hospital, Whipps Cross University Hospital were added.
14/11/2022: Publication reference added.
11/03/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2021 to 31/12/2022.
2. The overall trial end date was changed from 31/12/2022 to 30/04/2023.
3. The following trial participating centres were added: Ormskirk & District General Hospital, The Whittington Hospital, Chelsea and Westminster Hospital, West Middlesex University Hospital, Queen Elizabeth the Queen Mother Hospital, The Maidstone Hospital, The Tunbridge Wells Hospital, Sunderland Royal Hospital, South Tyneside District Hospital, Singleton Hospital, Neath Port Talbot Hospital, Royal Gwent Hospital, Nevill Hall Hospital, York Hospital, Scarborough General Hospital, Lister Hospital, Luton & Dunstable Hospital, Blackpool Victoria Hospital, Hull Royal Infirmary, Poole General Hospital, Musgrove Park Hospital, St Richard’s Hospital, Worthing Hospital, Burton Hospital, Wrexham Maelor Hospital, Ysbyty Glan Clwyd, Ysbyty Gwynedd, Pinderfields General Hospital, Cumberland Infirmary, West Cumberland Hospital, Warrington Hospital, Basildon University Hospital, Queen Elizabeth Hospital, Furness General Hospital, Royal Albert Edward Infirmary, University Hospital Crosshouse, Wishaw General Hospital, Chesterfield Royal Hospital, St Mary's Hospital, Birmingham Women’s Hospital, Barnet Hospital, Royal Free Hospital, East Surrey Hospital, Yeovil District Hospital, Royal Preston Hospital, Birmingham City Hospital, Arrowe Park Hospital, Hereford County Hospital, University Hospital of Wales, James Cook Hospital, Aberdeen Maternity Hospital, Stepping Hill Hospital, Ipswich Hospital, Epsom Hospital, St Helier Hospital, Scunthorpe General Hospital, Goole and District Hospital, Countess of Chester Hospital, Milton Keynes Hospital, Dorset County Hospital, Kettering General Hospital, North Tyneside General Hospital, Northumbria Specialist Care Hospital, Wansbeck Hospital, James Paget University Hospital, The Queen Elizabeth Hospital, King’s Lynn, Manor Hospital, Prince Charles Hospital, Princess of Wales Hospital, Watford General Hospital, West Suffolk Hospital.
4. The study contact details were updated.
5. The target number of participants was changed from 7000 to 4000.
15/02/2022: The following changes were made to the trial record:
1. The overall end date was changed from 28/02/2022 to 31/12/2022.
2. The plain English summary was updated to reflect these changes.
06/07/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2020 to 31/12/2021.
2. The overall end date was changed from 30/06/2021 to 28/02/2022.
3. The intention to publish date was changed from 30/06/2022 to 30/12/2023.
4. The acronym was added.
5. The plain English summary was updated to reflect these changes.
22/05/2020: Recruitment to this study is no longer paused.
20/04/2020: Due to current public health guidance, recruitment for this study has been paused.
27/03/2019: The condition has been changed from "Specialty: Reproductive health and childbirth, Primary sub-specialty: General Obstetrics/ Midwifery; UKCRC code/ Disease: Reproductive Health and Childbirth/ Complications of labour and delivery" to "Maternal care for suspected macrosomia" following a request from the NIHR.
14/11/2018: Study contact, trial participating centres and exclusion criteria updated.
25/04/2018: Internal review.