Amniotic Fluid Optical Density Determination Between 28 and 36 6/7 Weeks of Pregnancy and Its Relationship With the Diagnosis of Neonatal Respiratory Distress Syndrome.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Respiratory Distress Syndrome, Newborn
研究概览
简要总结
To determine the relationship between the result of amniotic fluid optical density between 26 and 36 6/7 weeks of pregnancy and the risk of developing neonatal respiratory distress syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnancy between 26 and 36 6/7 weeks.
排除标准
- •Problems in the handling of the amniotic fluid sample that prevented the calculation of the optical density.
研究组 & 干预措施
Preterm fetus
Patients with pregnancies between 26 and 36 6/7 weeks of pregnancy. Before the birth, a sample of amniotic fluid was taken and analyzed using optical density at 650nm. A value above 0.15 was considered an indication of fetal lung maturity.
干预措施: Preterm fetus (Procedure)
结局指标
主要结局
Respiratory Distress Syndrome, Newborn
时间窗: 1 month
Diagnosis of Respiratory Distress Syndrome in the neonatal period. The diagnosis was made by the neonatologist in charge (using clinical and radiological parameters).
次要结局
未报告次要终点
研究者
Osvaldo A. Reyes T.
Coordinator of Research
Saint Thomas Hospital, Panama