NCT01206946Unknown2 期
Effect of Antenatal Steroids for Women at Risk of Late Preterm Delivery on Neonatal Respiratory Morbidity
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 700
- 试验地点
- 5
- 主要终点
- Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN)
研究概览
简要总结
The hypothesis of the study is that administration of antenatal steroid to women at high risk of preterm birth after 34 weeks of gestation would reduce the risk of respiratory complications, specifically Respiratory Distress Syndrome (RDS) or Transient Tachypnea of the Newborn (TTN) in late preterm babies.
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
- •Women between 34 0/7- 36 6/7 weeks of gestation
- •High risk of preterm birth
排除标准
- •Multiple births
- •Fetal congenital malformations
- •A course of steroids within 2 weeks of randomization
- •Multiple courses of steroids
- •Chorioamnionitis
- •Non reassuring fetal heart rate
- •Obstetrical indication of delivery
- •Active bleeding
- •Pregnancy related hypertensive disorders
- •Uncontrolled diabetes
研究组 & 干预措施
Antenatal steroids
Experimental
干预措施: Betamethasone (Drug)
Normal saline
Placebo Comparator
干预措施: Normal Saline (Other)
结局指标
主要结局
Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN)
时间窗: First three days of life
次要结局
- Admission to NICU(First three days of life)
- Hospital stay(Neonatal period (28 days of life))
- Days on oxygen(Neonatal period (28 days of life))
- Intubations(First three days of life)
- Surfactant treatment(First three days of life)
- Pneumothorax(First three days of life)
- Persistent Pulmonary Hypertension of the Newborn(PPHN)(First three days of life)
- Days on ventilation(Neonatal period (28 days of life))
- Necrotizing enterocolitis (NEC)(Neonatal period (28 days of life))
- Clinical sepsis(Neonatal period (28 days of life))
- Intraventricular Hemorrhage (IVH)(First week after birth)
研究者
研究点 (5)
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