Birth WeightNCT03223363
A New Birth Weight Prediction in Chinese Population
A study testing 2D and 3D ultrasonography in people with Birth Weight, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
To determine the value of principal component analysis in the combined method of three-dimensional ultrasonography assessing fetal limb volume and circumference and conventional two-dimensional ultrasonography for prediction of birth weight in southern Chinese population. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Weight
- What is being tested?
- 2D and 3D ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2016to 1 Sep 2021
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The inclusion criteria consisted of well-defined gestational age (GA), singleton pregnancy and delivery in our hospital within 7 days from the scan performed for acquisition of 2D and 3D ultrasonographic data.
Who cannot join
- The exclusion criteria were equivocal GA, multiple pregnancy, fetal severe malformation detected by prenatal ultrasonographic scans, delivery more than 7 days after the scan of 2D and 3D ultrasonography, and delivery in other institutions.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Fang Yang, +86-13268251649, fangfangy@hotmail.com
About this study
Official title: A New Birth Weight Prediction Based on Ultrasonography in Chinese Population
To determine the value of principal component analysis in the combined method of three-dimensional ultrasonography assessing fetal limb volume and circumference and conventional two-dimensional ultrasonography for prediction of birth weight in southern Chinese population.
Read the detailed description
A prospective study was performed on single pregnant women in third trimester. Three- and two-dimensional ultrasonography for fetal biometric parameters were measured within 7 days of delivery. Stepwise linear regression were used to develop a new prediction model based on values from limb parameters and traditional measurements in development group. Estimated and actual birth weight were compared between the new model and previously published formulas on absolute error and percentage error. The accuracy of the model in predicting fetal birth weight was reassured by validation group.
- Conditions
- Birth Weight
- Being tested
- 2D and 3D ultrasonography
- Keywords
- Birth weight Prediction, Two-dimensional Ultrasonography, Three-dimensional Ultrasonography
- Medical subject headings
- Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D and 3D ultrasonographyDiagnostic test
All of the examinations are performed with the same transabdominal ultrasonic transducer (RAB 2-5-D) on the same E8 (GE Medical Systems, Milwaukee, WI, USA) ultrasonic machine experienced operators. 2D ultrasonic measurements includes 5 standard fetal biometry parameters, and after routine 2D ultrasonography, the acquisition of 3D measurements are performed.
| Study group | Role | What they receive |
|---|---|---|
| Development Group | Experimental | Development Group is used to establish the prediction model.2D and 3D ultrasonography are performed in this group. Through statistical analysis we obtain a new model. Receives: Diagnostic Test: 2D and 3D ultrasonography |
| Validation group | Other | Validation Group is used to confirm the efficacy of the prediction model.2D and 3D ultrasonography are performed in this group.Absolute and percentage error are calculated and compared with a common formula to confirm the accuracy of this new model. Receives: Diagnostic Test: 2D and 3D ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated birth weight in g
Estimated birth weight (g) calculated by a new formula generated from ultrasonograohic parameters in development group using statistical analysis.
Measured: 7 days within delivery
Secondary outcomes (2)
Absolute error in g
Absolute error (g) calculated from estimated birth weight (g) and actual birth weight (g)
Measured: After birth
Percentage error in %
Percentage error (%) calculated from estimated birth weight (g) and actual birth weight (g)
Measured: After birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Sep 2016
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2021 (estimated)
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 Nanfang Hospital, Southern Medical UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhujiang Hospital
- Responsible party
- Sponsor
- Investigators
- Fang Yang, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223363
- Sponsor's protocol ID
- LC2016PY021
- Status last verified
- Jul 2017
- First submitted
- 6 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nardozza LM, Caetano AC, Zamarian AC, Mazzola JB, Silva CP, Marcal VM, Lobo TF, Peixoto AB, Araujo Junior E. Fetal growth restriction: current knowledge. Arch Gynecol Obstet. 2017 May;295(5):1061-1077. doi: 10.1007/s00404-017-4341-9. Epub 2017 Mar 11.
PubMed 28285426
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Birth Weight Prediction Based on Ultrasonography in Chinese Population
- ClinicalTrials.gov ID
- NCT03223363
- Acronym / sponsor ID
- LC2016PY021
- Conditions
- Birth Weight
- Keywords
- Birth weight Prediction, Two-dimensional Ultrasonography, Three-dimensional Ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Zhujiang Hospital
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 21 Jul 2017 (actual)
- 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.
To determine the value of principal component analysis in the combined method of three-dimensional ultrasonography assessing fetal limb volume and circumference and conventional two-dimensional ultrasonography for prediction of birth weight in southern Chinese population.
Detailed description
A prospective study was performed on single pregnant women in third trimester. Three- and two-dimensional ultrasonography for fetal biometric parameters were measured within 7 days of delivery. Stepwise linear regression were used to develop a new prediction model based on values from limb parameters and traditional measurements in development group. Estimated and actual birth weight were compared between the new model and previously published formulas on absolute error and percentage error. The accuracy of the model in predicting fetal birth weight was reassured by validation group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Development Group | Experimental | Diagnostic Test: 2D and 3D ultrasonographyDevelopment Group is used to establish the prediction model.2D and 3D ultrasonography are performed in this group. Through statistical analysis we obtain a new model. |
| Validation group | Other | Diagnostic Test: 2D and 3D ultrasonographyValidation Group is used to confirm the efficacy of the prediction model.2D and 3D ultrasonography are performed in this group.Absolute and percentage error are calculated and compared with a common formula to confirm the accuracy of this new model. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria consisted of well-defined gestational age (GA), singleton pregnancy and delivery in our hospital within 7 days from the scan performed for acquisition of 2D and 3D ultrasonographic data.
Key exclusion criteria (1 listed)
- The exclusion criteria were equivocal GA, multiple pregnancy, fetal severe malformation detected by prenatal ultrasonographic scans, delivery more than 7 days after the scan of 2D and 3D ultrasonography, and delivery in other institutions.
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 |
|---|---|---|
| 2D and 3D ultrasonographyAll of the examinations are performed with the same transabdominal ultrasonic transducer (RAB 2-5-D) on the same E8 (GE Medical Systems, Milwaukee, WI, USA) ultrasonic machine experienced operators. 2D ultrasonic measurements includes 5 standard fetal biometry parameters, and after routine 2D ultrasonography, the acquisition of 3D measurements are performed. | Diagnostic test | Development Group, Validation group |
Primary outcome
Estimated birth weight in g
Time frame: 7 days within delivery
Estimated birth weight (g) calculated by a new formula generated from ultrasonograohic parameters in development group using statistical analysis.
2 secondary outcomes
Absolute error in g
Time frame: After birth
Percentage error in %
Time frame: After birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Background: PubMed 28285426Nardozza LM, Caetano AC, Zamarian AC, Mazzola JB, Silva CP, Marcal VM, Lobo TF, Peixoto AB, Araujo Junior E. Fetal growth restriction: current knowledge. Arch Gynecol Obstet. 2017 May;295(5):1061-1077. doi: 10.1007/s00404-017-4341-9. Epub 2017 Mar 11.
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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.
Fang Yang study chair
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2D and 3D ultrasonography in people with Birth Weight, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang Yang (+86-13268251649, fangfangy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated birth weight in g (time frame: 7 days within delivery). 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 NCT03223363, 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 21 Jul 2017.