Trials. 2024 Apr 12;25(1):258. doi: 10.1186/s13063-024-07941-0.
Preterm birth complications are the leading cause of newborn and under-5 mortality. Over 85% of all preterm births occur in the late preterm period, i.e. between 34 and < 37 weeks of gestation. Antenatal corticosteroids (ACS) prevent mortality and respiratory morbidity when administered to women at high risk of an early preterm birth, i.e. < 34 weeks' gestation. However, the benefits and risks of ACS in the late preterm period are less clear; both guidelines and practices vary between settings. Emerging evidence suggests that the benefits of ACS may be achievable at lower doses than presently used. This trial aims to determine the efficacy and safety of two ACS regimens compared to placebo, when given to women with a high probability of late preterm birth, in hospitals in low-resource countries.
WHO ACTION III trial is a parallel-group, three-arm, individually randomized, double-blind, placebo-controlled trial of two ACS regimens: dexamethasone phosphate 4 × 6 mg q12h or betamethasone phosphate 4 × 2 mg q 12 h. The trial is being conducted across seven sites in five countries-Bangladesh, India, Kenya, Nigeria, and Pakistan. Eligible women are those with a gestational age between 34 weeks 0 days and 36 weeks 5 days, who have a high probability of preterm birth between 12 h and 7 days (up to 36 weeks 6 days gestation). The primary outcome is a composite of stillbirth or neonatal death within 72 h of birth or use of newborn respiratory support within 72 h of birth or prior to discharge from hospital, whichever is earlier. Secondary outcomes include safety and health utilization measures for both women and newborns. The sample size is 13,500 women.
This trial will evaluate the benefits and possible harms of ACS when used in women likely to have a late preterm birth. It will also evaluate a lower-dose ACS regimen based on literature from pharmacokinetic studies. The results of this trial will provide robust critical evidence on the safe and appropriate use of ACS in the late preterm period internationally.
ISRCTN11434567 . Registered on 7 June 2021.
早产并发症是导致新生儿和 5 岁以下儿童死亡的主要原因。超过 85%的早产发生在晚期早产，即妊娠 34 周至<37 周之间。产前皮质类固醇（ACS）在高危孕妇早产，即<34 周妊娠时使用，可预防死亡率和呼吸发病率。然而，ACS 在晚期早产中的益处和风险尚不清楚；在不同环境中，指南和实践存在差异。新出现的证据表明，ACS 的益处可以通过低于目前使用的剂量来实现。本试验旨在确定在低资源国家的医院中，两种 ACS 方案与安慰剂相比，在有晚期早产高概率的妇女中使用的疗效和安全性。
世卫组织行动 III 试验是一项平行组、三臂、个体随机、双盲、安慰剂对照试验，比较两种 ACS 方案：磷酸地塞米松 4×6mg q12h 或磷酸倍他米松 4×2mg q12h。该试验在五个国家的七个地点进行，孟加拉国、印度、肯尼亚、尼日利亚和巴基斯坦。符合条件的妇女是那些妊娠年龄在 34 周 0 天至 36 周 5 天之间，在 12 小时至 7 天（最长至 36 周 6 天妊娠）之间有早产高概率的妇女。主要结局是出生后 72 小时内仍有死产或新生儿死亡，或出生后 72 小时内使用新生儿呼吸支持，或在出院前，以先发生者为准的复合结局。次要结局包括母婴安全和健康利用措施。样本量为 13500 名妇女。
本试验将评估 ACS 在可能发生晚期早产的妇女中使用的益处和可能的危害。它还将评估基于药代动力学研究文献的低剂量 ACS 方案。该试验的结果将为 ACS 在晚期早产中的安全和适当使用提供国际上强有力的关键证据。
ISRCTN85611315. 于 2021 年 6 月 7 日注册。
