Induction of labour for predicted macrosomia: the Big Baby trial
| ISRCTN | ISRCTN18229892 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18229892 |
| IRAS number | 229163 |
| Secondary identifying numbers | CPMS 36723, IRAS 229163 |
- Submission date
- 04/04/2018
- Registration date
- 12/04/2018
- Last edited
- 10/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
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
Scientific
Warwick Clinical Trials Unit
Warwick Medical School
Gibbet Hill Campus
University of Warwick
Coventry
CV4 7AL
United Kingdom
| Phone | +44 (0)24 76 151825 |
|---|---|
| Bigbaby@warwick.ac.uk |
Scientific
Warwick Clinical Trials Unit
Warwick Medical School
Gibbet Hill Campus
University of Warwick
Coventry
CV4 7AL
United Kingdom
| Phone | +44 (0)24 76 151825 |
|---|---|
| Bigbaby2Up@warwick.ac.uk |
Study information
| Study design | Randomized; Both; Design type: Treatment, Other |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Will be available at: http://warwick.ac.uk/bigbaby |
| Scientific title | Induction of labour for predicted macrosomia: the Big Baby trial |
| Study acronym | Big Baby |
| Study hypothesis | 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 |
| Condition | 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 | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2018 |
| Overall study end date | 26/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 4000; UK Sample Size: 4000 |
| Total final enrolment | 2895 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/05/2018 |
| Recruitment end date | 25/11/2022 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Coventry
CV2 2DX
United Kingdom
Shrewsbury
SY3 8XQ
United Kingdom
Warwick
CV34 5BW
United Kingdom
Liverpool
L8 7SS
United Kingdom
Birmingham
B9 5SS
United Kingdom
Nuneaton
CV10 7DJ
United Kingdom
Oldham
OL1 2JH
United Kingdom
Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom
Huddersfield Road
Halifax
HX3 0PW
United Kingdom
Acre Street
Huddersfield
HD3 3EA
United Kingdom
Darlington
DL3 6HX
United Kingdom
Durham
DH1 5TW
United Kingdom
Burnley
BB10 2PQ
United Kingdom
Blackburn
BB2 3HH
United Kingdom
Casterton Avenue
Burnley
BB10 2PQ
United Kingdom
Frimley
GU16 7UJ
United Kingdom
Slough
SL2 4HL
United Kingdom
London
W12 0HS
United Kingdom
Leeds
LS1 3EX
United Kingdom
Leeds
LS9 7TF
United Kingdom
Manchester
M13 9WL
United Kingdom
Crewe
CW1 4QJ
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Hardwick Road
Stockton-On-Tees
Cleveland
TS19 8PE
United Kingdom
Huntingdon
PE29 6NT
United Kingdom
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Salisbury
SP2 8BJ
United Kingdom
Sutton-In-Ashfield
NG17 4JL
United Kingdom
Prescot
L35 5DR
United Kingdom
Worcester
WR5 1DD
United Kingdom
Ormskirk
L39 2AZ
United Kingdom
London
N19 5NF
United Kingdom
London
SW10 9NH
United Kingdom
Isleworth
TW7 6AF
United Kingdom
Margate
CT9 4AN
United Kingdom
Maidstone
ME16 9QQ
United Kingdom
Tonbridge Road
Pembury
Tunbridge Wells
TN2 4QJ
United Kingdom
Sunderland
SR4 7TP
United Kingdom
South Shields
NE34 0PL
United Kingdom
Sketty
Swansea
SA2 8QA
United Kingdom
Port Talbot
SA12 7BX
United Kingdom
Newport
NP20 2UB
United Kingdom
NP7 7EG
United Kingdom
York
YO31 8HE
United Kingdom
Scarborough
YO12 6QL
United Kingdom
Stevenage
SG1 4AB
United Kingdom
Luton
LU4 0DZ
United Kingdom
Blackpool
FY3 8NR
United Kingdom
Hull
HU3 2JZ
United Kingdom
Longfleet Road
Poole
BH15 2JB
United Kingdom
Taunton
TA1 5DA
United Kingdom
Chichester
PO19 6SE
United Kingdom
Worthing
BN11 2DH
United Kingdom
New Street
Burton -on-trent
DE14 3QH
United Kingdom
Wrexham Technology Park
Wrexham
LL13 7TD
United Kingdom
Rhuddlan Road
Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom
Wakefield
WF1 4DG
United Kingdom
Carlisle
CA2 7HY
United Kingdom
Hensingham
Whitehaven
CA28 8JG
United Kingdom
Lovely Lane
Warrington
WA5 1QG
United Kingdom
Basildon
SS16 5NL
United Kingdom
Gateshead
NE9 6SX
United Kingdom
Barrow-in-furness
LA14 4LF
United Kingdom
Wigan
WN1 2NN
United Kingdom
Kilmarnock
KA2 0BE
United Kingdom
Wishaw
ML2 0DP
United Kingdom
Calow
Chesterfield
S44 5BL
United Kingdom
Newport
PO30 5TG
United Kingdom
Edgbaston
Birmingham
B15 2TG
United Kingdom
Barnet
EN5 3DJ
United Kingdom
London
NW3 2QG
United Kingdom
Redhill
RH1 5RH
United Kingdom
Yeovil
BA21 4AT
United Kingdom
Fulwood
Preston
PR2 4BR
United Kingdom
Birmingham
B18 7QH
United Kingdom
Wirral
CH49 5PE
United Kingdom
Hereford
HR1 2ER
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Aberdeen
AB25 2ZL
United Kingdom
Poplar Grove
Hazel Grove
Stockport
SK2 7JE
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Dorking Road
Epsom
KT18 7EG
United Kingdom
Carshalton
SM5 1AA
United Kingdom
Scunthorpe
DN15 7BH
United Kingdom
Goole
DN14 6RX
United Kingdom
Liverpool Road
Chester
CH2 1UL
United Kingdom
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Dorchester
DT1 2JY
United Kingdom
Kettering
NN16 8UZ
United Kingdom
North Shields
NE29 8NH
United Kingdom
Cramlington
NE23 6NZ
United Kingdom
Ashington
NE63 9JJ
United Kingdom
Gorleston
Great Yarmouth
NR31 6LA
United Kingdom
King's Lynn
PE30 4ET
United Kingdom
Walsall
WS2 9PS
United Kingdom
Merthyr Tydfil
CF47 9DT
United Kingdom
Bridgend
Bridgend County Borough
CF31 1RQ
United Kingdom
Watford
WD18 0HB
United Kingdom
Bury St. Edmunds
IP33 2QZ
United Kingdom
Truro
TR1 3LJ
United Kingdom
Leytonstone
London
E11 1NR
United Kingdom
Sponsor information
Hospital/treatment centre
Clifford Bridge Road
Coventry
CV2 2DX
England
United Kingdom
| Phone | +44 (0)2476 966195 |
|---|---|
| r&dsponsorship@uhcw.nhs.uk | |
"ROR" |
https://ror.org/025n38288 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The trialists aim to publish an article in the British Journal of Midwifery. They will also publish the protocol and the final trial results in fully open access high impact peer reviewed journals. They will submit abstracts to major national and international conferences, including RCM, RCPCH annual conferences, RCOG World Congress, and British Maternal and Fetal Medicine conference, for dissemination to service users, researchers, public health and NHS sectors. They will hold three dissemination events in three locations, Manchester, Coventry and London and invite key stakeholders at the end of the study, including participants, representatives from PPI organisations, clinicians (midwives and doctors) involved in the care of pregnant women, research midwives who worked on the study, managers, policy makers and experts in the field. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 11/11/2022 | 14/11/2022 | Yes | No | |
| Statistical Analysis Plan | version 4.0 | 10/02/2023 | 23/06/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
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.
