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临床试验/NCT02541110
NCT02541110Unknown不适用

Second Trimester Maternal Serum Homocysteine Level & Uterine Artery Doppler for Prediction of Preeclampsia , Intra-Uterine Growth Retardation (IUGR) & Other Obstetric Complications

Kasr El Aini Hospital0 个研究点目标入组 200 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
主要终点
Number of pregnants who developed preeclampsia, those who developed IUGR alone and those who developed other obstetric complications as preterm labour and placental abruption

研究概览

简要总结

Second trimester homocysteine & uterine artery doppler will be assessed& the cases will be followed up till delivery for development of preeclampsia, IUGR(intra-uterine growth retardation) & other obstetric complications.

详细描述

Spontaneous pregnancies with no risk factors will be included. Fasting plasma total homocysteine level samples will be collected between 15th & 19th weeks.

Uterine artery doppler between 18th & 22nd weeks.

Method 1: Screen positive cases will be considered if homocysteine level above 6.3umol/l

Method 2: Screen positive cases will be considered if they had bilateral notches and a mean resistivity index (RI) above 0.55, or unilateral notches and a mean RI above 0.65, or absence of notches and a mean RI above 0.7.

Method 3: Screen positive cases will be considered if they had bilateral notches and a mean RI above 0.55, or unilateral notches and a mean RI above 0.65, or absence of notches and a mean RI above 0.7 combined with homocysteine cut off value of 6.3umol / l.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • spontaneous pregnancies with no risk factors

排除标准

  • multiple pregnancies
  • non intact renal function
  • hypertension
  • folic acid supplements
  • antifolate drugs

结局指标

主要结局

Number of pregnants who developed preeclampsia, those who developed IUGR alone and those who developed other obstetric complications as preterm labour and placental abruption

时间窗: 4 months

次要结局

未报告次要终点

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

suzy abdelaziz Abdelhamid

lecturer of Obgyn

Kasr El Aini Hospital

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