search
Back to results

A New Birth Weight Prediction in Chinese Population

Primary Purpose

Birth Weight

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
2D and 3D ultrasonography
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Birth Weight focused on measuring Birth weight Prediction, Two-dimensional Ultrasonography, Three-dimensional Ultrasonography

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Development Group

Validation group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
July 6, 2017
Last Updated
July 17, 2017
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Zhujiang Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03223363
Brief Title
A New Birth Weight Prediction in Chinese Population
Official Title
A New Birth Weight Prediction Based on Ultrasonography in Chinese Population
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Zhujiang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Weight
Keywords
Birth weight Prediction, Two-dimensional Ultrasonography, Three-dimensional Ultrasonography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Development Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Validation group
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
2D and 3D ultrasonography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Estimated birth weight in g
Description
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 Outcome Measure Information:
Title
Absolute error in g
Description
Absolute error (g) calculated from estimated birth weight (g) and actual birth weight (g)
Time Frame
After birth
Title
Percentage error in %
Description
Percentage error (%) calculated from estimated birth weight (g) and actual birth weight (g)
Time Frame
After birth

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Yang
Phone
+86-13268251649
Email
fangfangy@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Yang
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Yang
Phone
+86-13268251649
Email
fangfangy@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
28285426
Citation
Nardozza LM, Caetano AC, Zamarian AC, Mazzola JB, Silva CP, Marcal VM, Lobo TF, Peixoto AB, Araujo Junior 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.
Results Reference
background

Learn more about this trial

A New Birth Weight Prediction in Chinese Population

We'll reach out to this number within 24 hrs