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临床试验/NCT04721782
NCT04721782Unknown不适用

Assessment of Effects of Maternal Smoking on Fetal Liver Circulation With Ultrasonography

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年7月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
1
主要终点
Comparison of hepatic venous flow between smoking and non- smoking pregnant women

研究概览

简要总结

According to the hypothesis of this study presented, the effects of smoking on the fetus can be determined by the liver circulation and hepatic metabolism. The basic assumption of this project is; Compensatory and pathological findings can be seen in the fetal liver circulation in babies of mothers who smoke and the findings can be valuable in predicting the direction of fetal development (growth retardation or normal development). In this study, the flow and shunt amounts in the fetal hepatic vessels in normal and smoking pregnant women will be calculated with the help of Doppler US.

详细描述

Smoking is an agent that negatively affects of uteroplacental circulation and fetal development due to the chemical substances it contains, especially carbon monoxide and nicotine. According to the hypothesis of this study presented, the effects of smoking on the fetus can be determined by the liver circulation and hepatic metabolism. The basic assumption of this project is; Compensatory and pathological findings can be seen in the fetal liver circulation in babies of mothers who smoke and the findings can be valuable in predicting the direction of fetal development (growth retardation or normal development). In this study, the flow and shunt amounts in the fetal hepatic vessels in normal and smoking pregnant women will be calculated with the help of Doppler US.Therefore, we try to delineate pathological circulatory pattern in these fetuses and shed light to the mechanism of smoking-induced abnormal fetal development. In addition, the effects of other maternal demographic factors, cigarette amount, cotinine and expiratory carbon monoxide levels (or any correlation between them) on hepatic circulation and fetal development will be examined.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton pregnancy
  • smoking more than one cigarette in a day

排除标准

  • fetal anomaly
  • pregnant women with systemic disease
  • younger than 18 years

结局指标

主要结局

Comparison of hepatic venous flow between smoking and non- smoking pregnant women

时间窗: 24-36 weeks of pregnancy

The evaluation of fetal flow parameters will be done with Voluson E6 and Philips EPIQ Elite ultrasound devices. In evaluations, diameters and the time avaraged flow velocities in intraabdominal umbilical vein, left portal vein, main portal vein and ductus venosus (DV) will be measured. The flow volumes will be calculated according to the specified formula and the venous flow of the right and left lobes of the liver and total venous flow of the liver will be determined, adjusted for estimated fetal weight and compared between groups. Flow Formulas; (QUV, QDV, QLPV, QPV): Total venous Hepatic Flow (Qhep)= (QUV-QDV) + QPV Flow to the left liver lobe(QLL)= QUV - (QDV + QleftPV) Flow to the right hepatic lobe (QrightLobe) = QPV + QleftPV

次要结局

  • Normal references values of fetal umbilical venous and portal venous flow in Turkish Population(24-36 weeks of pregnancy)
  • The effect of maternal smoking on fetal growth(24-36 weeks of pregnancy)
  • Sensitivity and specificity of maternal expiratory CO levels for detecting maternal smoking during pregnancy(24-36 weeks of pregnancy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Serdar Kutuk

Associate Professor

Bezmialem Vakif University

研究点 (1)

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