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Clinical Trials/NCT03223363
NCT03223363
Unknown
Not Applicable

A New Birth Weight Prediction Based on Ultrasonography in Chinese Population

Nanfang Hospital, Southern Medical University1 site in 1 country10,000 target enrollmentSeptember 1, 2016
ConditionsBirth Weight

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Birth Weight
Sponsor
Nanfang Hospital, Southern Medical University
Enrollment
10000
Locations
1
Primary Endpoint
Estimated birth weight in g
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2016
End Date
September 1, 2021
Last Updated
8 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Estimated birth weight in g

Time Frame: 7 days within delivery

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

Secondary Outcomes

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

Study Sites (1)

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