A New Birth Weight Prediction in Chinese Population

Not Applicable

• Conditions: Birth Weight
• Interventions: Diagnostic Test: 2D and 3D ultrasonography

• Registration Number: NCT03223363
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Study Start: 2016-09-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-17
• Last Update Submitted: 2017-07-17
• Study First Posted: 2017-07-21
• Last Update Posted: 2017-07-21
• Primary Completion: 2020-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Development Group	2D and 3D ultrasonography	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.
Validation group	2D and 3D ultrasonography	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.

Primary Outcome Measures

Name	Time	Method
Estimated birth weight in g	7 days within delivery	Estimated birth weight (g) calculated by a new formula generated from ultrasonograohic parameters in development group using statistical analysis.

Secondary Outcome Measures

Name	Time	Method
Absolute error in g	After birth	Absolute error (g) calculated from estimated birth weight (g) and actual birth weight (g)
Percentage error in %	After birth	Percentage error (%) calculated from estimated birth weight (g) and actual birth weight (g)

Trial Locations

Locations (1)

Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China