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临床试验/CTRI/2018/08/015286
CTRI/2018/08/015286招募中不适用

Comparison of outcome of Low-risk and High-risk pregnancies based on fetal cerebroplacental ratio assessed by Doppler studies

Kerala Institute of Medical Science1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年12月4日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Perinatal outcome - Admission in NICU

研究概览

简要总结

FGRis normally used to refer to small fetuses with higher risk for fetal inuterodeterioration, stillbirth and overall poorer perinatal outcome as compared withnormally grown fetuses. They are associated with Doppler signs suggestinghemodynamic redistribution as a reflection of fetal adaptation to undernutrition /hypoxia, histological and biochemical signs of placental disease anda higher risk of preeclampsia. The term SGA has been used to differentiate asubgroup of small fetuses that do not present the changes described above. Whilethe concepts of FGR and SGA may be clear, distinction of ‘True FGR’ in clinicalpractice can be challenging.

Population based seriesshow that prenatal identification of SGA babies’ results in a reduction ofadverse perinatal outcome and stillbirth. However, most SGA babies remainunnoticed until birth, even when routine third trimester ultrasound isperformed. In late SGA fetuses, abnormal CPR is present before deliveryin 20-25% of the cases. We propose that low fetal CPR is associated withadverse perinatal outcome. This study aims to evaluate the Cerebro PlacentalRatio, which is the ratio of Pulsatality Index of fetal middle cerebral and UmbilicalArtery, in normal and high-risk pregnancies during 28 – 36 weeks of gestationand compare the fetal and neonatal outcome.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Low-risk Pregnancy a.Singleton pregnancy b.Gestational age of patient should be between 30 and 38 weeks 2.High-risk Pregnancy a.Singleton pregnancy b.Gestational age of patient should be between 30 and 38 weeks c.At least one of the following risk factor was present in study group pregnant women.
  • i.Gestational hypertension ii.Essential hypertension iii.Prior neonatal death iv.Diabetes mellitus v.Malnutrition vi.Anemia.

排除标准

  • 1.Multiple Pregnancy 2.Congenital anomalies in fetus 3.Not willing to participate.

结局指标

主要结局

Perinatal outcome - Admission in NICU

时间窗: Up to two week post delivery

次要结局

  • Obstetrical outcome - Mode of Delivery

研究者

申办方类型
Research institution and hospital

研究点 (1)

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