Twins at term Pregnancy and Childbirth Twin birth
Conditions
Interventions
Elective birth at 37 weeks gestation compared with standard care
Sponsors
The University of Adelaide (Australia)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women with a twin pregnancy at 37 weeks gestation
Exclusion criteria
Exclusion criteria: Women with any of the following will be excluded from the trial: intrauterine fetal death of one or both fetuses at the time of trial entry; active labour; fetal distress or non-reassuring fetal heart rate trace; maternal or fetal compromise precluding continued antenatal surveillance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite mortality and morbidity index has been chosen as the primary outcome for the trial. For a policy of elective birth at 37 weeks gestation to be justified in clinical practice, there must be an important benefit of reduced perinatal mortality or serious adverse outcome for the infants defined as one or more of the following occurring within six weeks postpartum: 1. Perinatal mortality defined as any fetal death after trial entry, or death of a liveborn infant within 28 days of age (excluding lethal congenital anomalies); or 2. Serious neonatal morbidity defined as one or more of the following, excluding lethal congenital anomalies: birth trauma (subdural or intracerebral haemorrhage, spinal cord injury, basal skull fracture, other fracture, peripheral nerve injury present at discharge from hospital); birth weight -8; seizures at 24 hours; use of tube feeding >4 days; admission to neonatal intensive care unit (NICU) >4 days; severe respiratory distress syndrome (mean arterial pressure [MAP] >10 and or FiO2 >0.8 with need for ventilation); proven necrotising enterocolitis; proven systemic infection within 48 hours of birth treated with antibiotics. These definitions of adverse outcome are those used by the Australian and New Zealand Neonatal Network (Donoghue 2000), and those considered by experts as important measures of term and post-term neonatal morbidity (Hannah 1992). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Antenatal medical and obstetric defined complications 2. Labour and birth defined complications 3. Adverse outcomes for the infant defined 4. Serious adverse outcome for the woman defined as a composite endpoint of birth 5. Maternal physical wellbeing 6. Maternal emotional wellbeing 7. Maternal satisfaction with care 8. Longer term health, growth and development of the infant | — |
Countries
Australia
Outcome results
None listed