The C*STEROID Feasibility Study: a two-site, randomised placebo controlled trial of corticosteroids before planned caesarean section delivery at 35+0 to 39+6 weeks of pregnancy to determine feasibility for recruitment to the C*STEROID Trial.

Phase 3

• 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: ACTRN12618002028280
• Lead Sponsor: niversity of Auckland

Brief Summary

This study was done as the first stage of a larger study, The C*STEROID Trial, with the aim to understand whether giving mothers’ corticosteroid injections before planned caesarean section (CS) birth at 35+0 to 39+6 weeks can safely reduce the risk of breathing problems for babies. Our goal for the initial C*STEROID Feasibility Study was to understand how many women may be willing to take part, and to identify ways to help this process run smoothly for women, their families, and our staff. The results will also contribute to the larger C*STEROID Trial. Recruitment concluded slightly earlier than expected due to the impact of COVID-19 in March 2020; however, we were still able to gain the valuable information we needed to answer all of our research questions. The recruitment rate was 8.9% (88/987) overall and 11.2% (88/789) for those approached about the trial. Neonatal blood glucose concentrations were measured as planned in 87/92 (94.6%) babies. For potential participants, key enablers to participation were contributing to research, a feeling of relevance and a good understanding; key barriers were a lack of understanding and concerns over safety. For researchers and clinicians, themes representing enablers and barriers included relevance, communication and awareness, influences on women’s decision-making, resource challenges and trial process practicalities.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-18
• Study Completion: 2020-04-29
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 88

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.

Exclusion Criteria

1. Diabetes: pre-existing or gestational.
2. Non-viable fetus or major fetal abnormality.
3. Prior corticosteroid use in this pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Trial recruitment rate: number recruited/number of eligible participants.[Six and twelve months after commencing recruitment. ]