A New Birth Weight Prediction in Chinese Population

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03223363

Collaborator

Zhujiang Hospital (Other)

10,000

Enrollment

Location

Arms

Anticipated Duration (Months)

166.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Birth Weight	Diagnostic Test: 2D and 3D ultrasonography	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10000 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

A New Birth Weight Prediction Based on Ultrasonography in Chinese Population

Actual Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Development Group 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.	Diagnostic Test: 2D and 3D ultrasonography 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.
Other: Validation group 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.	Diagnostic Test: 2D and 3D ultrasonography 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.

Arm

Intervention/Treatment

Experimental: Development Group

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.

Diagnostic Test: 2D and 3D ultrasonography

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.

Other: Validation group

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.

Diagnostic Test: 2D and 3D ultrasonography

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.