A New Birth Weight Prediction in Chinese Population

Birth Weight Clinical Trial

Official title:

A New Birth Weight Prediction Based on Ultrasonography in Chinese Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03223363
• Other study ID #: LC2016PY021
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2017
• Last updated: July 17, 2017
• Start date: September 1, 2016
• Est. completion date: September 1, 2021

Study information

• Verified date: July 2017
• Source: Nanfang Hospital of Southern Medical University
• Contact: Fang Yang
• Phone: +86-13268251649
• Email: fangfangy[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Body Weight

Intervention

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.

Locations

Country	Name	City	State
China	Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Zhujiang Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Nardozza LM, Caetano AC, Zamarian AC, Mazzola JB, Silva CP, Marçal VM, Lobo TF, Peixoto AB, Araujo Júnior E. Fetal growth restriction: current knowledge. Arch Gynecol Obstet. 2017 May;295(5):1061-1077. doi: 10.1007/s00404-017-4341-9. Epub 2017 Mar 11. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated birth weight in g	Estimated birth weight (g) calculated by a new formula generated from ultrasonograohic parameters in development group using statistical analysis.	7 days within delivery
Secondary	Absolute error in g	Absolute error (g) calculated from estimated birth weight (g) and actual birth weight (g)	After birth
Secondary	Percentage error in %	Percentage error (%) calculated from estimated birth weight (g) and actual birth weight (g)	After birth