We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Automated Fetal Weight Estimation: A Multicenter Validation Using Fractional Limb Volume

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03002246
Recruitment Status : Completed
First Posted : December 23, 2016
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
Samsung Medison Co., Ltd.
Beijing Obstetrics and Gynecology Hospital
Frauenklinik der Diakonischen Dienste Hannover
University of Pittsburgh
Information provided by (Responsible Party):
Wesley Lee, Baylor College of Medicine

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This trial is a collaborative study between 4 sites worldwide. A total of 600 research subjects will be enrolled. We will investigate the validity of using 5D Limb Volume software to improve on estimated fetal weight predictions over a broad range of gestational ages. The purpose is to compare the accuracy and precision of birth weight predictions based on this new technology as compared to the current 2D birth weight prediction models.

Condition or disease Intervention/treatment
Birth Weight Fetal Growth Retardation Fetal Weight Fetal Macrosomia Other: Ultrasound Examination

Detailed Description:

Ultrasound has been used for over 20 years to estimate fetal weight prior to birth. Sometimes this estimation is not always similar to what the baby actually weighs. In addition to the regular measurements taken at routine ultrasound exams, 3D ultrasound of the baby's arm and leg soft tissue may give us more precise information on how much the baby weighs. This measurement is called fractional limb volume. Fractional limb volume (FLV) is a soft tissue measurement of the arm or thigh that can be used to evaluate body composition. This measurement mostly reflects the fat and muscle development with a small amount of bone.

The recent introduction of 5D Limb Volume software (Samsung, Seoul, Korea) now makes it possible to efficiently and reproducibly measure semi-automated FLV using a computer guided technique.

Subjects will receive one ultrasound scan 4-7 days before their delivery. Both 2D and 3D measurements will be taken. These measurements will then be used to estimate fetal weight. We will compare estimated weight to actual birth weight in order to determine the accuracy and precision of the 5D Limb Volume technology. This data may also be used to develop new weight estimation models that could provide better accuracy and/or precision than what is currently provided using published methods.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Automated Fetal Weight Estimation: A Multicenter Validation Using Fractional Limb Volume
Actual Study Start Date : January 6, 2017
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Average for Gestational Age
This cohort will include a sample size of 90 subjects. Fetuses will have an estimated fetal weight greater than 10th percentile and less than 90th percentile based on clinical ultrasound assessment. This cohort will receive an ultrasound examination 4-7 days before their delivery.
 Other: Ultrasound Examination
Research volunteers will be invited to have a 2D/3D ultrasound research scan 4-7 days from delivery.This ultrasound scan will take approximately 30 minutes to complete.
Large for Gestational Age
This cohort will include a sample size of 30 subjects. Fetuses will have an estimated fetal weight greater than 90th percentile based on clinical ultrasound assessment.This cohort will receive an ultrasound examination 4-7 days before their delivery.
 Other: Ultrasound Examination
Research volunteers will be invited to have a 2D/3D ultrasound research scan 4-7 days from delivery.This ultrasound scan will take approximately 30 minutes to complete.
Small for Gestational Age
This cohort will include a sample size of 30 subjects. Fetuses will have an estimated fetal weight less than 10th percentile based on clinical ultrasound assessment.This cohort will receive an ultrasound examination 4-7 days before their delivery.
 Other: Ultrasound Examination
Research volunteers will be invited to have a 2D/3D ultrasound research scan 4-7 days from delivery.This ultrasound scan will take approximately 30 minutes to complete.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Comparison Between 5D Limb Vol and 2D Birth weight Prediction [ Time Frame: Feb 2017 -Feb 2018 ]
    Compare the accuracy and precision of BW predictions based on 5D Limb Vol technology in pregnant women as compared to 2D BW prediction models


Secondary Outcome Measures :
  1. Birth weight Predictions in Suspected Growth Abnormalities [ Time Frame: Feb 2017 - Feb 2018 ]
    Characterize the performance of BW predictions based on 5D Limb Vol technology in pregnant women with suspected growth abnormalities.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women between 28-42 weeks gestation. Fetuses will be either small for gestational age (estimated fetal weight < 10%), average for gestational age, or large for gestational age (estimated fetal weight > 90%).
Criteria

Inclusion Criteria:

  1. Pregnant women (28-42 weeks) within 4-7 days of delivery
  2. Planned delivery at the collaborating hospital where the fetal US scan was performed
  3. Body mass index at first official prenatal appointment below 35.0 kg/M2
  4. Firm US dating criteria (early crown-rump length < 14 weeks gestational age)

Exclusion Criteria:

  1. Presence of technical factors (e.g. obesity) that make it difficult to visualize fetal structures
  2. Oligohydramnios determined by amniotic fluid index less than 5cm
  3. Fetal distress or unstable maternal condition
  4. Structural or chromosomal fetal anomalies
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03002246


Sponsors and Collaborators
Baylor College of Medicine
Samsung Medison Co., Ltd.
Beijing Obstetrics and Gynecology Hospital
Frauenklinik der Diakonischen Dienste Hannover
University of Pittsburgh
Investigators
Layout table for investigator information
Principal Investigator: Wesley Lee, MD Baylor College of Medicine
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Wesley Lee, Dr. Wesley Lee, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03002246    
Other Study ID Numbers: H-39343
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Fetal Growth Retardation
Fetal Macrosomia
Body Weight
Birth Weight
Fetal Weight
Fetal Diseases
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Growth Disorders
Pathologic Processes
Diabetes, Gestational
Pregnancy in Diabetics
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases