Skip to main content
Clinical Trials/ACTRN12618002028280
ACTRN12618002028280
Terminated
Phase 3

The C*STEROID Feasibility Study: Corticosteroids before planned caesarean section from 35+0 to 39+6 weeks

niversity of Auckland0 sites88 target enrollmentDecember 18, 2018

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Caesarean section delivery
Sponsor
niversity of Auckland
Enrollment
88
Status
Terminated
Last Updated
3 years ago

Overview

Brief Summary

This study was done as the first stage of a larger study, The CSTEROID 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 CSTEROID 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.

Registry
who.int
Start Date
December 18, 2018
End Date
April 29, 2020
Last Updated
3 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
niversity of Auckland

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

Similar Trials