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临床试验/ACTRN12618002028280
ACTRN12618002028280终止3 期

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

niversity of Auckland0 个研究点目标入组 88 人开始时间: 2018年12月18日最近更新:
适应症

试验速览

阶段
3 期
状态
终止
发起方
入组人数
88

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Blinded (masking used)

入排标准

年龄范围
14 Years 至 55 Years(—)
性别
Female

入选标准

  • 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.

排除标准

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

研究者

发起方
niversity of Auckland

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