Assessment of neonatal morbidity and need for respiratory support for twins born by planned birth (caesarean section or induction of labour) between 35+0 and 38+6 weeks gestation Neonatal Diseases
Conditions
Interventions
Participants will be randomised by a simple allocation sequence with no minimisation criteria due to the large sample size (1552 women). Women will be asked to attend the hospital for administration o
Sponsors
University of Edinburgh
NHS Lothian
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 16 years or older and able to provide electronic or written consent 2. Women presenting with a viable twin pregnancy (monochorionic or dichorionic) with a planned birth (caesarean section or induction of labour) scheduled between 35+0 and 38+6 weeks gestation including women who have a planned birth due to logistic reasons (e.g. availability of beds or staff), parental preference or other maternal or fetal indications. 3. Women with gestation established by scan at =16 weeks according to NICE guidelines and known chorionicity 4. =24 hours and <7 days until planned birth
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 14/01/2025: 1. Women who are unable to give informed consent 2. Women who have a known or suspected major congenital fetal anomaly at the time of inclusion (defined as any structural or chromosomal anomaly that would influence management at or around birth or in the immediate postnatal period. Suspected isolated minor anomalies with lesser medical, functional or cosmetic consequences; or isolated limb abnormalities such as talipes can be included). 3. Women who have received ACS within the seven days prior to randomisation 4. Women who have a sensitivity, contraindication or intolerance to any of the ACS or any of its excipients 5. Women in whom chorionicity or gestational age are unknown 6. Women with other serious pregnancy morbidities which indicate either birth before 35 weeks or urgent birth within 24 hours 7. Women involved in a clinical trial of an investigational medicinal product (CTIMP) in pregnancy Previous exclusion criteria: 1. Women who are unable to give informed consent 2. Women who have a known or suspected major congenital fetal anomaly at the time of inclusion (defined as any structural or chromosomal anomaly that would influence management at or around birth or in the immediate postnatal period. Suspected isolated minor anomalies with lesser medical, functional or cosmetic consequences; or isolated limb abnormalities such as talipes can be included). 3. Diabetes (pre-existing or gestational) 4. Women who have received ACS within the seven days prior to randomisation 5. Women who have a sensitivity, contraindication or intolerance to any of the ACS or any of its excipients 6. Women in whom chorionicity or gestational age are unknown 7. Women with other serious pregnancy morbidities which indicate either birth before 35 weeks or urgent birth within 24 hours 8. Women involved in a clinical trial of an investigational medicinal product (CTIMP) in pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neonatal morbidity including the need for respiratory support within 72 hours of birth, assessed using neonatal and delivery records. This is a composite outcome encompassing a range of levels of support consisting of one or more of the following: 1. Continuous positive airway pressure (CPAP) 2. Supplemental oxygen by high-flow nasal cannulae for at least 2 consecutive hours 3. Need for supplemental oxygen by low flow nasal cannulae or incubator oxygen for at least 4 continuous hours 4. Mechanical ventilation 5. Extracorporeal membrane oxygenation (ECMO) 6. Stillbirth 7. Neonatal death within 72 hours of birth | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Severe respiratory morbidity assessed using neonatal and delivery records, a composite outcome of one or more of the following within 72 hours of birth: 1.1. CPAP or high-flow nasal cannula for at least 12 continuous hours 1.2. Supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at least 24 continuous hours 1.3. Mechanical ventilation 1.4. ECMO 1.5. Stillbirth 1.6. Neonatal death within 72 hours of birth 2. Other perinatal morbidity assessed using neonatal and delivery records: 2.1. Any admission to NNU (i.e. admission for any reason and for any duration) between birth and 28 days 2.2. NNU admission within 72 hours of birth for 48 hours or more or any NNU admission (within 28 days of birth) or those requiring surfactant treatment or nitric oxide therapy 2.3. Apgar score at 5 minutes after birth 2.4. Umbilical arterial cord pH at birth 2.5. Umbilical arterial cord base excess at birth 2.6. The number of newborns with hypoglycaemia (defined as blood glucose of less than 2.0 mmol per litre or treatment for hypoglycaemia administered) at birth 2.7. The number of newborns with neonatal jaundice (defined as those requiring treatment with phototherapy according to the NICE threshold for gestation and postnatal age) at birth 2.8. Birthweight at birth 2.9. Head circumference at birth 2.10. All-cause early-onset sepsis within 72 hours of birth (defined as culture positive [pure growth from blood or CSF of a known bacterial pathogen] or culture-negative [acute onset of illness with three or more predefined clinical signs]) 3. Perinatal mortality assessed using neonatal and delivery records: 3.1. Extended perinatal mortality (stillbirth or neonatal death up to 28 days) 3.2. Stillbirth (death in utero) 3.3. Neonatal death (death within 28 days of birth) 4. Maternal outcomes assessed using maternity records: 4.1. Exclusive breastmilk nutrition at discharge 4.2. Confirmed or suspected postpartum infection during hospital admission (defined by a new pres | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactDenise;Denise Cranley;Cranley
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Outcome results
None listed