Diastolic Deceleration Area in Severe Early-onset Growth Restriction of the Fetus
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
- Hypoxia in the newborn
研究概览
简要总结
DDA is a new Doppler parameter aiming to assess fetal well-being in-utero. Early-onset SGR is a specific subgroup of fetuses where the clinical application of this Doppler modality could play an important role in the detection of hypoxia, anemia, and brain-sparing.
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 before 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 before 32nd week of gestation
结局指标
主要结局
Hypoxia in the newborn
时间窗: immediately after delivery
Defined by pH values below 7.20 in the umbilical artery
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
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
次要结局
- Apgar score at 10th minute(10 minutes after delivery)
- Apgar score at 1st minute(1 minute after delivery)
- Apgar score at 5th minute(5 minutes after delivery)
- Admissions to a NICU(first 72 hours after delivery)
研究者
Petar Ignatov
Assoc. prof. Petar Ignatov, M.D., Ph. D.
Orthogyn Medical Center, Bulgaria