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临床试验/NCT03962153
NCT03962153已完成不适用

New Ultrasonographic Parameters for Fetal Weight Prediction

University of Campania "Luigi Vanvitelli"1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
transtentorial diameter

研究概览

简要总结

The hypothesis is to increase the predictability of the ultrasound examination evaluating new fetal parameters: in fact the thickness of the soft tissues can contribute significantly to the fetal weight and the characteristics of the thoracic cage may correlate with the fetal weight.

详细描述

Estimation of fetal weight (EFW: Estimated Fetal Weight) with ultrasound examination is a common practice in obstetrics and is important for planning the mode and timing of birth, especially in pregnancies at risk for altered fetal growth.

The conditions most commonly associated with impaired fetal growth are:

  • IUGR: in these cases the ultrasound estimate of fetal weight is fundamental to decide the timing of delivery, since the neonatal outcome correlates positively with the fetal weight as well as with the flowmetry parameters
  • fetal macrosomia (fetal weight greater than 4500 g) associated or not with gestational diabetes: in such cases an accurate estimation of the fetal weight is necessary and careful evaluation of any fetal-pelvic disproportion to decide both the timing of the birth that can be anticipated compared to at the physiological end of pregnancy is the mode of birth, vaginal or laparotomic in the event of a pelvic fetus disproportion.

In the 1970s the estimate of fetal weight was based on the measurement of the symphysis-fundus uterine distance (SFH) for which:

  • SFH <33 cm: predictive of a fetal weight <3100 gr
  • SFH> 34 cm: predictive of a fetal weight = o> 4000 gr.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women

排除标准

  • fetal structural and / or chromosomal anomalies
  • multiple pregnancies
  • premature births (gestational age <37w)

结局指标

主要结局

transtentorial diameter

时间窗: 9 months

Evaluation of transtentorial diameter

femur length

时间窗: 9 months

Evaluation of femur length

distance between L1-L4 lumbar vertebrae

时间窗: 9 months

Evaluation of distance between L1-L4

head circumference

时间窗: 9 months

evaluation of head circumference

abdominal circumference

时间窗: 9 months

Evaluation of abdominal circumference

Fetal Weight

时间窗: 9 months

Evaluation of Fetal Weight

biparietal diameter

时间窗: 9 months

Evaluation of biparietal diameter

次要结局

未报告次要终点

研究者

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

Prof. Pasquale De Franciscis

Associate Professor

University of Campania "Luigi Vanvitelli"

研究点 (1)

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