The C*STEROID Trial: Corticosteroids before planned caesarean section from 35+0 to 39+6 weeks of pregnancy.

Phase 3

Recruiting

• Conditions: Caesarean section delivery; Respiratory distress syndrome; Transient tachypnoea of the newborn; Neonatal hypoglycaemia; Respiratory - Other respiratory disorders / diseases; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12620000914965
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-16
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 2548

Inclusion Criteria

1. Women for whom caesarean section is planned pre-labour at 35+0 to 39+6 weeks gestation.
2. >24 hours and <7 days before planned birth.
3. Singleton or twin pregnancy with a live fetus.

Exclusion Criteria

1. Diabetes: pre-existing or gestational.
2. Major fetal abnormality.
3. Prior corticosteroid use in this pregnancy (intramuscular corticosteroid use for fetal lung maturity).
4. Prior enrolment in the C*STEROID Feasibility Study or C*STEROID Trial, in a previous pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of respiratory distress requiring >60 minutes of respiratory support (neonatal outcome). 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). >60 minutes has been selected to eliminate short-term support which may be subject to variation by clinician. Data will be collected by review of hospital/neonatal unit records.[ Primary hospital discharge];Incidence of neonatal hypoglycaemia (blood glucose level <2.6 mmol/L) prior to primary hospital discharge. Data will be collected by review of hospital records and/or glucose oxidase test results.[ Primary hospital discharge]