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

NCT03002246 | Completed

• 1 other identifier: H-39343
• Study Type: observational
• Target: 330
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Birth Weight; Fetal Growth Retardation; Fetal Weight; Fetal Macrosomia

Outcome Measures

Primary Outcomes (1)

• Comparison Between 5D Limb Vol and 2D Birth weight Prediction

  Compare the accuracy and precision of BW predictions based on 5D Limb Vol technology in pregnant women as compared to 2D BW prediction models

  Feb 2017 -Feb 2018

Secondary Outcomes (1)

• Birth weight Predictions in Suspected Growth Abnormalities

  Feb 2017 - Feb 2018

Study Arms (3)

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

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

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

Interventions

Ultrasound Examination OTHER

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.

Average for Gestational Age; Large for Gestational Age; Small for Gestational Age

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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%).

You may qualify if:

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

You may not qualify if:

• Presence of technical factors (e.g. obesity) that make it difficult to visualize fetal structures
• Oligohydramnios determined by amniotic fluid index less than 5cm
• Fetal distress or unstable maternal condition
• Structural or chromosomal fetal anomalies

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Samsung Medison Co., Ltd.: collaborator
• Beijing Obstetrics and Gynecology Hospital: collaborator
• Frauenklinik der Diakonischen Dienste Hannover: collaborator
• University of Pittsburgh: collaborator

Related Publications (1)

• Kang L, Wu QQ, Sun LJ, Gao FY, Wang JJ. Predicting fetal weight by three-dimensional limb volume ultrasound (AVol/TVol) and abdominal circumference. Chin Med J (Engl). 2021 Apr 20;134(9):1070-1078. doi: 10.1097/CM9.0000000000001413.

  PMID: 33883411 DERIVED

MeSH Terms

Conditions

Birth Weight; Fetal Growth Retardation; Fetal Weight; Fetal Macrosomia

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Wesley Lee, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Wesley Lee

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 23, 2016
• Study Start: January 6, 2017
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share