| Study name |
The C*STEROID Trial: Corticosteroids before planned caesarean section from 35+0 to 39+6 weeks of pregnancy |
| Methods |
Randomised controlled trial
Setting: New Zealand
Blinding: participants, care provider, outcome assessor and investigator |
| Participants |
Inclusion criteria
Women age 14 to 55 years for whom caesarean section is planned pre‐labour at 35 + 0 to 39 + 6 weeks gestation > 24 hours and < 7 days before planned birth Singleton or twin pregnancy
Exclusion criteria
Diabetes: pre‐existing or gestational Non‐viable fetus or major fetal abnormality Prior corticosteroid use in this pregnancy
"We will recruit 2548 infants (1274 per group)" |
| Interventions |
Intervention group: two doses of 11.4 mg betamethasone by intramuscular injection into the thigh, arm or buttock, 24 hours apart given within seven days of planned caesarean section.
Control group: placebo ‐ 0.9% NaCl in a visually matching syringe |
| Outcomes |
Co‐primary outcomes
Neonatal benefit: incidence of respiratory distress requiring > 60 minutes* of respiratory support. Includes mechanical and non‐invasive ventilation where sum of both is > 60 minutes (e.g. intermittent positive pressure via endotracheal tube, nasal continuous positive airway pressure, Hi‐ or Lo‐flow oxygen/air mix or increased ambient oxygen delivered into an incubator) Neonatal harm: incidence of hypoglycaemia (blood glucose level < 2.6 mmol/L) prior to primary hospital discharge
* > 60 minutes selected to eliminate short‐term support which may be subject to variation by clinician.
Secondary outcomes
NNU admission Duration of NNU stay Duration of neonatal hospital stay (to primary hospital discharge) Duration of neonatal respiratory support (sum of mechanical and non‐invasive) Severe respiratory distress defined as any mechanical ventilation and/or need for surfactant therapy; moderate respiratory distress defined as respiratory support (sum of mechanical and non‐invasive) for > 24 hours Severe neonatal hypoglycaemia defined as blood glucose level < 1.2 mmol/L Early onset infection and/or late onset infection as defined by ANZNN Maternal self‐reported adverse effects of injections including gastrointestinal upset; insomnia; pain, bruising or infection at injection site Maternal perinatal infectious morbidity requiring postpartum antibiotic therapy Duration of maternal postnatal stay (to primary hospital discharge) Breastfeeding (exclusive and full) at six weeks postpartum Maternal well‐being and psychological status measured at six weeks postpartum
|
| Starting date |
4 June 2019 |
| Contact information |
A/Prof Katie Groom
Associate Professor of Maternal and Perinatal Health
Hugo Charitable Trust Research Fellow
Maternal Fetal Medicine Subspecialist
The University of Auckland, 85 Park Road, Grafton
Private Bag 92019, Auckland 1142, New Zealand
+64 9 373 7599 ext 89823
k.groom@auckland.ac.nz |
| Notes |
Contacted principal investigator asking for data for women at 37 weeks and beyond. Reply from Prof Groom:
"The C*STEROID Feasibility Study has now completed recruitment but we remain blinded to results by treatment group as clinical outcomes will also contribute to the main C*STEROID Trial. This was planned a priori. The main trial has commenced recruitment and we expect a 3‐4 year timeline to complete. We will be happy to share results once the trial is completed and results analysed." |
