Antenatal Corticoid Therapy for Fetal Lung Maturation in Late Preterm Pregnancies: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- neonatal respiratory distress
研究概览
简要总结
This study aims to determine the effectiveness of antenatal corticosteroid therapy in late preterm babies. The investigators hypothesis is corticoid accelerates fetal lung maturation even after 34 weeks and reduces risk of respiratory distress syndrome and other neonatal morbidities.
详细描述
Late preterm babies have important morbidity when compared with term babies, with oxygen requirement and more days of hospitalization. If antenatal corticosteroid therapy is necessary for fetal lung maturation after 34 weeks, it remains to be established. The systematic review with metanalysis in Cochrane Library includes a small number of late preterm babies and no conclusion about effectiveness of corticoid therapy in this setting could be drawn. Our hypothesis is that antenatal corticosteroid therapy is effective to prevent respiratory disease and morbidity in late preterm babies and this study will be carried out to evaluate this question.
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
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnancy between 34 and 36 weeks
- •Confirmed gestational age (LMP, USG)
- •Alive fetus
- •Imminent risk of preterm delivery
排除标准
- •Multiple pregnancy
- •Major fetal malformations
- •Comproved fetal lung maturity
- •Maternal or fetal indication for immediate interruption of pregnancy
- •Maternal hemorrhagic syndromes (placenta previa, abruptio placenta)
- •Chorioamnionitis
- •Chronic use of corticosteroids
- •Previous use of corticosteroids for fetal lung maturation in the current pregnancy
研究组 & 干预措施
A
Antenatal corticoid therapy
干预措施: Betamethasone (Drug)
结局指标
主要结局
neonatal respiratory distress
时间窗: neonatal period (28 days of life)
次要结局
- neonatal death(neonatal period (28 days of life))
- during of neonatal hospitalization(neonatal period (28 days of life))
- neonatal sepsis(neonatal period (28 days of life))
- neonatal oxygen requirement(neonatal period (28 days of life))