Maternal care for suspected macrosomia
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
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
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