ACTRN12617000476336终止3 期
WHO ACTION-I Trial: A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries to improve newborn outcomes
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2,852
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- All
入选标准
- •Birth planned or expected within 48 hours
- •-Gestational age from 26 weeks 0 days to 33 weeks 6 days (see Figure 3)
- •-Women with singleton or multiple pregnancies, where the fetus(es) is(are) alive
- •-Women with no clinical signs of severe infection (as per clinical assessment)
- •-Women willing and able to provide consent (or if a minor, provides assent and guardian provides consent)
排除标准
- •1. Intrauterine fetal death
- •2. Major or lethal congenital fetal anomaly identified
- •3. Clinical suspicion or evidence of clinical chorioamnionitis, as per obstetric care physician assessment
- •4. Clinical suspicion or evidence of severe infection, as per obstetric care physician assessment
- •5. No prior ultrasound-based estimate of gestational age available and immediate ultrasound examination is not possible
- •6. Any concurrent or recent (within the past 2 weeks) systemic corticosteroid use during the current pregnancy (outside of trial)
- •7. Unwilling or unable to provide consent
- •8. Currently a participant in another clinical trial related to maternal and neonatal health
- •9. Any other clinical indication where the treating clinician considers corticosteroids to be contraindicated
研究者
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