Diastolic Deceleration Area (DDA) in Late-onset Fetal Growth Restriction (FGR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Occurence of hypoxic-ischemic encephalopathy
研究概览
简要总结
DDA is a new Doppler parameter aiming to assess fetal well-being in-utero. Late-onset FGR is a specific subgroup of fetuses where the clinical application of this Doppler modality could play an essential role in detecting hypoxia, anemia, and other adverse neonatal outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •absence of fetal abnormalities and/or genetic conditions;
- •single pregnancy;
- •fetal growth restriction (FGR) < 10%, according to the INTERGROWTH 21st nomograms, appearing after 32nd week of gestation
排除标准
- •documented fetal abnormalities and/or genetic conditions in the course of the pregnancy;
- •multiple pregnancy;
- •absence of fetal growth restriction (FGR) < 10%, according to the INTERGROWTH 21st nomograms after 32nd week of gestation
结局指标
主要结局
Occurence of hypoxic-ischemic encephalopathy
时间窗: first 72 hours after delivery
Occurence of hypoxic-ischemic encephalopathy in relation to some of the outcome measures
Hypoxia in the newborn
时间窗: immediately after delivery
Defined by pH values \< 7.20
Anemia in the newborn
时间窗: immediately after delivery
Hemoglobin deviation from GA mean - mild \< 20 g/L, moderate - 20-70 g/L, severe \> 70 g/L
次要结局
- Admissions to a NICU(first 72 hours after delivery)
- Apgar score at 1st minute(1 minute after delivery)
- Apgar score at 5th minute(5 minutes after delivery)
- Apgar score at 10th minute(10 minutes after delivery)
研究者
Petar Ignatov
Assoc. prof. Petar Ignatov, M.D., Ph. D.
Orthogyn Medical Center, Bulgaria