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临床试验/NCT03223363
NCT03223363Unknown不适用

A New Birth Weight Prediction Based on Ultrasonography in Chinese Population

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10,000
试验地点
1
主要终点
Estimated birth weight in g

研究概览

简要总结

To determine the value of principal component analysis in the combined method of three-dimensional ultrasonography assessing fetal limb volume and circumference and conventional two-dimensional ultrasonography for prediction of birth weight in southern Chinese population.

详细描述

A prospective study was performed on single pregnant women in third trimester. Three- and two-dimensional ultrasonography for fetal biometric parameters were measured within 7 days of delivery. Stepwise linear regression were used to develop a new prediction model based on values from limb parameters and traditional measurements in development group. Estimated and actual birth weight were compared between the new model and previously published formulas on absolute error and percentage error. The accuracy of the model in predicting fetal birth weight was reassured by validation group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • The inclusion criteria consisted of well-defined gestational age (GA), singleton pregnancy and delivery in our hospital within 7 days from the scan performed for acquisition of 2D and 3D ultrasonographic data.

排除标准

  • The exclusion criteria were equivocal GA, multiple pregnancy, fetal severe malformation detected by prenatal ultrasonographic scans, delivery more than 7 days after the scan of 2D and 3D ultrasonography, and delivery in other institutions.

研究组 & 干预措施

Development Group

Experimental

Development Group is used to establish the prediction model.2D and 3D ultrasonography are performed in this group. Through statistical analysis we obtain a new model.

干预措施: 2D and 3D ultrasonography (Diagnostic Test)

Validation group

Other

Validation Group is used to confirm the efficacy of the prediction model.2D and 3D ultrasonography are performed in this group.Absolute and percentage error are calculated and compared with a common formula to confirm the accuracy of this new model.

干预措施: 2D and 3D ultrasonography (Diagnostic Test)

结局指标

主要结局

Estimated birth weight in g

时间窗: 7 days within delivery

Estimated birth weight (g) calculated by a new formula generated from ultrasonograohic parameters in development group using statistical analysis.

次要结局

  • Absolute error in g(After birth)
  • Percentage error in %(After birth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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