Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,858
- 试验地点
- 2
- 主要终点
- MACS: Perinatal or neonatal mortality or serious neonatal morbidity
研究概览
简要总结
In women at 26 to 30 weeks gestation and who are risk for threatened early birth, who have not had their baby by 14 or more days after being given a single course of antenatal corticosteroids (ACS), do repeated courses of ACS every 14 days until 33 weeks' gestational age lower the risk of illness or death in babies compared to repeated courses of placebo. Children are assessed at 2 years and 5 years for neurodevelopmental impairment.
详细描述
In women at 26 to 30 weeks gestation, who are at increased risk for preterm birth and remain undelivered 14 or more days following a single course of antenatal corticosteroids (ACS), are multiple course of ACS every 14 days until 33 weeks effective in reducing the risk of perinatal or neonatal mortality or significant neonatal morbidity, compared to placebo.
18-24 Month Follow-up: Children (18-24 months corrected gestational age) are assessed with the Bayley Scales of Infant Development (Second Edition) to determine neurodevelopmental impairment.
5 Year Follow-up (MACS-5): Children are assessed using the Child Behaviour Checklist (1 1/2 - 5) and the Behaviour Rating Inventory of Executive Function (Preschool version) to determine neurocognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have previously received one completed course of ACS, at least 14 days ago and continue to be at increased risk of preterm birth
- •Gestational age greater ≥ 26 weeks and gestational age < 31 weeks
排除标准
- •Women requiring chronic doses of corticosteroids secondary to medical conditions
- •Women with a contraindication to corticosteroids
- •Women with clinical evidence of chorioamnionitis (temperature ≥ 38°c)
- •Known lethal congenital anomaly (e.g. anencephaly)
结局指标
主要结局
MACS: Perinatal or neonatal mortality or serious neonatal morbidity
MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age
次要结局
- MACS: Death or neurologic impairment at 2 years of age
- MACS-5: Measures of growth and blood pressure assessed by clinical exam
- MACS-5: At Canadian sites, abnormalities in intelligence and specific cognitive skills (WPPSI-III, Beery: VMI and PPVT-III)