Condition category
Pregnancy and Childbirth
Date applied
04/04/2018
Date assigned
12/04/2018
Last edited
25/04/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 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 June 2021

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

Who is the main contact?
Mr Ryan Griffin
BigBaby@warwick.ac.uk

Trial website

http://warwick.ac.uk/bigbaby

Contact information

Type

Scientific

Primary contact

Mr Ryan Griffin

ORCID ID

Contact details

University Hospital Coventry and Warwickshire
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+44 (0)2476968663
BigBaby@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36723

Study information

Scientific title

Induction of labour for predicted macrosomia: the Big Baby trial

Acronym

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

South West-Exeter Research Ethics Committee, 19/03/2018, ref: 18/SW/0039

Study design

Randomised; Both; Design type: Treatment, Other

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Will be available at: http://warwick.ac.uk/bigbaby

Condition

Specialty: Reproductive health and childbirth, Primary sub-specialty: General Obstetrics/ Midwifery; UKCRC code/ Disease: Reproductive Health and Childbirth/ Complications of labour and delivery

Intervention

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

Phase

Drug names

Primary outcome measures

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

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 trial start date

01/01/2018

Overall trial end date

30/06/2021

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 7000; UK Sample Size: 7000

Participant 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

30/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital Coventry and Warwickshire
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

Shrewsbury and Telford Hospital NHS Trust
Mytton Oak Road
Shrewsbury
SY3 8XQ
United Kingdom

Trial participating centre

South Warwickshire NHS Foundation Trust
Lakin Road
Warwick
CV34 5BW
United Kingdom

Sponsor information

Organisation

University Hospitals Coventry and Warwickshire NHS Trust

Sponsor details

Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+44 (0)2476 966195
r&dsponsorship@uhcw.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/77/02

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/06/2022

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

25/04/2018: Internal review.