PRECeDe Pilot: Prevention of neonatal Respiratory distress with antenatal corticosteroids prior to Elective Caesarean section in women with Diabetes - A Feasibility Randomised Trial

Phase 2

Completed

• Conditions: Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Reproductive Health and Childbirth - Childbirth and postnatal care; Reproductive Health and Childbirth - Antenatal care; Reproductive Health and Childbirth - Breast feeding; Respiratory - Other respiratory disorders / diseases; Metabolic and Endocrine - Diabetes; Surgery - Other surgery; Diabetes; Gestational Diabetes; Neonatal respiratory distress

• Registration Number: ACTRN12619001475134
• Lead Sponsor: Western Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-24
• Study Completion: 2022-06-08
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 47

Inclusion Criteria

Women with a singleton or twin pregnancy between 35+0 and 38+6 weeks who have pre-gestational diabetes OR gestational diabetes (diagnosed on a pregnancy 75g Oral glucose tolerance test according to the WHO criteria for gestational diabetes)
AND
plan to give birth by elective caesarean section within the next 7 days.

Exclusion Criteria

1.Known major fetal anomaly or chromosomal anomaly.
2.Administration of any corticosteroid therapy within the last 7 days.
3.Contraindication to corticosteroids

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of all eligible women who consent and are randomised during the time period of the study.[ Completion of recruitment]