Birth WeightNCT03002246
Automated Fetal Weight Estimation: A Multicenter Validation Using Fractional Limb Volume
An observational study of Birth Weight and Fetal Growth Retardation, run by Baylor College of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Birth Weight, Fetal Growth Retardation, Fetal Weight
- What is being tested?
- Ultrasound Examination
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- 6 Jan 2017to 31 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
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%).
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Birth Weight, Fetal Growth Retardation, Fetal Weight, Fetal Macrosomia
- Being tested
- Ultrasound Examination
- Medical subject headings
- Birth Weight, Fetal Growth Retardation, Fetal Weight, Fetal Macrosomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ExaminationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Ultrasound Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Feb 2017 -Feb 2018
Secondary outcomes (1)
Birth weight Predictions in Suspected Growth Abnormalities
Characterize the performance of BW predictions based on 5D Limb Vol technology in pregnant women with suspected growth abnormalities.
Measured: Feb 2017 - Feb 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start6 Jan 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birth WeightStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medison Co., Ltd., Beijing Obstetrics and Gynecology Hospital, Frauenklinik der Diakonischen Dienste Hannover, University of Pittsburgh
- Responsible party
- Principal investigator, Wesley Lee, Baylor College of Medicine
- Investigators
- Wesley Lee, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002246
- Sponsor's protocol ID
- H-39343
- Status last verified
- Jul 2019
- First submitted
- 21 Dec 2016
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 33883411
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Fetal Weight Estimation: A Multicenter Validation Using Fractional Limb Volume
- ClinicalTrials.gov ID
- NCT03002246
- Acronym / sponsor ID
- H-39343
- Conditions
- Birth Weight, Fetal Growth Retardation, Fetal Weight, Fetal Macrosomia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Samsung Medison Co., Ltd., Beijing Obstetrics and Gynecology Hospital, Frauenklinik der Diakonischen Dienste Hannover, University of Pittsburgh
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Average for Gestational Age | – | Other: Ultrasound ExaminationThis 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. |
| Large for Gestational Age | – | Other: Ultrasound ExaminationThis 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. |
| Small for Gestational Age | – | Other: Ultrasound ExaminationThis 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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%).
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound ExaminationResearch 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. | Other | Average for Gestational Age, Large for Gestational Age, Small for Gestational Age |
Primary outcome
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
1 secondary outcome
Birth weight Predictions in Suspected Growth Abnormalities
Time frame: Feb 2017 - Feb 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Derived from this study: PubMed 33883411Kang 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wesley Lee, MD principal investigator
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Birth Weight and Fetal Growth Retardation, run by Baylor College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison Between 5D Limb Vol and 2D Birth weight Prediction (time frame: Feb 2017 -Feb 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03002246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.