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

NCT03002246 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2019-07-23

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Samsung Medison Co., Ltd.

    collaborator UNKNOWN
  • Beijing Obstetrics and Gynecology Hospital

    collaborator OTHER
  • Frauenklinik der Diakonischen Dienste Hannover

    collaborator UNKNOWN
  • University of Pittsburgh

    collaborator OTHER
  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Wesley Lee, MD · Baylor College of Medicine

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-06
Primary Completion
2019-01-31
Completion
2019-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03002246 on ClinicalTrials.gov