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Completed

NCT Number: NCT03002246

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Beijing Obstetrics and Gynecology Hospital
  • Frauenklinik der Diakonischen Dienste Hannover
  • Samsung Medison Co., Ltd.
  • University of Pittsburgh

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 23, 2016
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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