A New Birth Weight Prediction in Chinese Population
1 other identifier
interventional
10,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 6, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedJuly 21, 2017
July 1, 2017
4 years
July 6, 2017
July 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Absolute error in g
After birth
Percentage error in %
After birth
Study Arms (2)
Development Group
EXPERIMENTALDevelopment 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
OTHERValidation 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.
Interventions
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 Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Zhujiang Hospitalcollaborator
Study Sites (1)
Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Related Publications (1)
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.
PMID: 28285426BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fang Yang
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2017
First Posted
July 21, 2017
Study Start
September 1, 2016
Primary Completion
September 1, 2020
Study Completion
September 1, 2021
Last Updated
July 21, 2017
Record last verified: 2017-07