A New Birth Weight Prediction in Chinese Population

Nanfang Hospital, Southern Medical University10,000 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Enrollment

10,000

Conditions

Birth Weight

Interventions

2D and 3D ultrasonographyDIAGNOSTIC_TEST

All of the examinations are performed with the same transabdominal ultrasonic transducer (RAB 2-5-D) on the same E8 (GE Medical Systems, Milwaukee, WI, USA) ultrasonic machine experienced operators. 2D ultrasonic measurements includes 5 standard fetal biometry parameters, and after routine 2D ultrasonography, the acquisition of 3D measurements are performed.

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Estimated birth weight in g

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

Time frame: 7 days within delivery

Secondary Outcomes

Absolute error in g

Absolute error (g) calculated from estimated birth weight (g) and actual birth weight (g)

Time frame: After birth

Percentage error in %

Percentage error (%) calculated from estimated birth weight (g) and actual birth weight (g)

Time frame: After birth

Central Contacts

Fang Yang

CONTACT

+86-13268251649 fangfangy@hotmail.com

Data from ClinicalTrials.gov

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