Trials. 2019 Aug 16;20(1):507. doi: 10.1186/s13063-019-3488-z.
Antenatal corticosteroids (ACS) have long been regarded as a cornerstone intervention in mitigating the adverse effects of a preterm birth. However, the safety and efficacy of ACS in hospitals in low-resource countries has not been established in an efficacy trial despite their widespread use. Findings of a large cluster-randomized trial in six low- and middle-income countries showed that efforts to scale up ACS use in low-resource settings can lead to harm. There is equipoise regarding the benefits and harms of ACS use in hospitals in low-resource countries. This randomized controlled trial aims to determine whether ACS are safe and efficacious when given to women at risk of imminent birth in the early preterm period, in hospitals in low-resource countries.
METHODS/DESIGN: The trial design is a parallel, two-arm, double-blind, individually randomized, placebo-controlled trial of ACS (dexamethasone) for women at risk of imminent preterm birth. The trial will recruit 6018 women in participating hospitals across five low-resource countries (Bangladesh, India, Kenya, Nigeria and Pakistan). The primary objectives are to compare the efficacy of dexamethasone with placebo on survival of the baby and maternal infectious morbidity. The primary outcomes are: 1) neonatal death (to 28 completed days of life); 2) any baby death (any stillbirth postrandomization or neonatal death); and 3) a composite outcome to assess possible maternal bacterial infections. The trial will recruit eligible, consenting pregnant women from 26 weeks 0 days to 33 weeks 6 days gestation with confirmed live fetuses, in whom birth is planned or expected within 48 h. The intervention comprises a regimen of intramuscular dexamethasone sodium phosphate. The comparison is an identical placebo regimen (normal saline). A total of 6018 women will be recruited to detect a reduction of 15% or more in neonatal deaths in a two-sided 5% significance test with 90% power (including 10% loss to follow-up).
Findings of this trial will guide clinicians, programme managers and policymakers on the safety and efficacy of ACS in hospitals in low-resource countries. The trial findings will inform updating of the World Health Organization's global recommendations on ACS use.
ACTRN12617000476336 . Registered on 31 March 2017.
产前皮质类固醇（ACS）长期以来一直被视为减轻早产不良影响的基石干预措施。然而，尽管 ACS 在低资源国家得到广泛应用，但在疗效试验中尚未确定其在这些国家的安全性和有效性。在六个中低收入国家进行的一项大型集群随机试验的结果表明，努力在资源匮乏的环境中扩大 ACS 的使用可能会导致危害。关于 ACS 在低资源国家医院使用的益处和危害存在平衡。这项随机对照试验旨在确定在低资源国家的医院中，即将早产的高危妇女使用 ACS（地塞米松）是否安全有效。
方法/设计：该试验设计是一项在五个低资源国家（孟加拉国、印度、肯尼亚、尼日利亚和巴基斯坦）参与医院的即将早产高危妇女中进行的平行、双臂、双盲、个体随机、安慰剂对照的 ACS（地塞米松）试验。该试验将招募 6018 名妇女。主要目标是比较地塞米松与安慰剂对婴儿存活和产妇感染发病率的疗效。主要结局为：1）新生儿死亡（至 28 天完成生命）；2）任何婴儿死亡（任何随机后死产或新生儿死亡）；3）评估可能的母体细菌感染的综合结局。该试验将招募符合条件、同意的孕妇，其妊娠 26 周 0 天至 33 周 6 天，胎龄确定，胎儿存活，分娩计划或预计在 48 小时内进行。干预措施包括肌内注射地塞米松磷酸钠。对照为相同的安慰剂方案（生理盐水）。共招募 6018 名妇女，以在双侧 5%显著性检验中检测新生儿死亡率降低 15%或更多，具有 90%的功效（包括 10%的随访损失）。
该试验的结果将为临床医生、项目管理人员和决策者提供关于 ACS 在低资源国家医院的安全性和有效性的指导。试验结果将为更新世界卫生组织关于 ACS 使用的全球建议提供信息。
ACTRN12617000476336。于 2017 年 3 月 31 日注册。
