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Trial record 13 of 1444 for:    Prediction | Recruiting, Not yet recruiting, Available Studies

A New Birth Weight Prediction in Chinese Population

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ClinicalTrials.gov Identifier: NCT03223363
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Zhujiang Hospital
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : September 1, 2016
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. Estimated birth weight in g [ Time Frame: 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 :
  1. Absolute error in g [ Time Frame: After birth ]
    Absolute error (g) calculated from estimated birth weight (g) and actual birth weight (g)

  2. Percentage error in % [ Time Frame: After birth ]
    Percentage error (%) calculated from estimated birth weight (g) and actual birth weight (g)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223363


Contacts
Contact: Fang Yang +86-13268251649 fangfangy@hotmail.com

Locations
China, Guangdong
Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Fang Yang    +86-13268251649    fangfangy@hotmail.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Zhujiang Hospital
Investigators
Study Chair: Fang Yang Nanfang Hospital of Southern Medical University

Publications:
Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03223363     History of Changes
Other Study ID Numbers: LC2016PY021
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nanfang Hospital of Southern Medical University:
Birth weight Prediction
Two-dimensional Ultrasonography
Three-dimensional Ultrasonography

Additional relevant MeSH terms:
Body Weight
Birth Weight
Signs and Symptoms