Maternal care for suspected macrosomia Pregnancy and Childbirth
Conditions
Interventions
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,
Sponsors
University Hospitals Coventry and Warwickshire NHS Trust
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 fr | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactKimberley;Kimberley Stewart;Stewart
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Outcome results
None listed