The proportion of all eligible women who consent and are randomised during the time period of the study
Rate of betamethasone use in eligible women outside of the study protocol assessed via data linkage to medical records
Assessment of patient, treating obstetrician and treating neonatologist’s (for infants admitted to special care unit only) prediction of treatment allocation
Time taken for research staff to screen, recruit, consent and randomise women
Time taken for research staff to administer interventional products and collect outcome data following birth up to the time of discharge from hospital of mother and/or infant
Time taken for research staff to follow up women and arrange completion of surveys at 6 weeks postpartum
Neonatal respiratory distress
Admission to neonatal nursery and length of stay.
Severity of respiratory distres
Need for and duration of any form of respiratory support (defined as intermittent positive pressure via an endotracheal tube, CPAP, Hi‐ or Lo‐flow oxygen/air mixture, or increased ambient oxygen delivered into an incubator (including therapy required for less than 4 hours).
Use of exogenous surfactant
Pneumothorax or air leak detected on chest radiograph requiring drainage
Presence of x‐ray features suggestive of hyaline membrane disease
Neonatal hypoglycaemia defined as any blood glucose concentration < 2.6 mmol/L
Neonatal hypoglycaemia defined as a blood glucose concentration < 2.6mmol/L requiring treatment other than feeding (including dextrose gel, intravenous dextrose, glucagon)
Requirement for additional insulin therapy for the mother to maintain fasting capillary blood sugars below 5.0 mmol/L or postprandial blood sugars below 6.7 mmol/L, following administration of study drug prior to the caesarean section. Participants will be provided with a diary to record all blood sugar levels following administration of study drug or placebo. Participants will be provided with instructions to contact an endocrinologist if they have 2 consecutive fasting blood sugars above 5.0 mmol/L or 2 consecutive postprandial blood sugars above 6.7 mmol/L OR if a single blood sugar is above 8.0 mmol/L.
Highest maternal blood glucose concentration recorded between randomisation and birth. Maternal blood sugars will be tested at least prior to every meal and 2 hours after every meal.
Maternal infection from the time of randomisation up until 6 weeks postpartum including chorioamnionitis (defined as clinical signs of chorioamnionitis requiring intrapartum antibiotics); maternal pyrexia 38°C or higher; wound infection requiring antibiotic treatment; surgical/ radiological drainage of wound collection
Maternally reported side effects of antenatal corticosteroid or placebo injections (e.g. pain at injection site, nausea, headaches, changes in fetal movements). Side‐effects will be reported through the use of a study specific questionnaire with several side effects listed but women will also be invited to report any additional symptoms they notice.
Maternal mental health assessment using the Edinburgh Postnatal Depression Scale (EPDS)
Maternal general health prior to randomisation and at 6 weeks postpartum using the SF36 and AQoL8D
Breastfeeding rates at hospital discharge and 6 weeks postpartum based on maternal self report through a study specific survey
