Reproducibility of the Measurement of the Right Portal Vein Diameter (PORTALGROWTH1)
Intra and Interoperator Reproducibility of the Measurement of the Right Portal Vein Diameter at the Third Trimester Scan
Although routine ultrasound is offered during the third trimester of pregnancy, less than a quarter of newborns with intrauterine growth retardation (IUGR) are suspected antenatally.
The measurement of the right portal vein (RPV) diameter on the transverse abdominal view at the 32 weeks' scan may be a new a tool for detecting small-for-gestational-age (SGA) at birth. The irregular and collapsed aspect of the right portal vein (RPV) on the third trimester ultrasound could be used for identifying hypoxemic and growth-restricted fetuses.
However, to our knowledge, the only interoperator reproducibility study of this measurement was performed using the same stored images or datasets without performing a new examination.
The main objective of this study is to assess the intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound.
The secondary objective is to quantify the interoperator reproducibility of the assessment of the aspect, normal or collapsed, of the right portal vein, using an evaluation grid.
Two referees will perform four successive measurements of the diameter of the right portal vein (RPV) during the same ultrasound examination at the third trimester. Each operator will qualify the appearance of the right portal vein as normal or collapsed using an evaluation grid, and will independently performe a series of two measurements using the same method.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Poitiers, France, 85000
- C.H.U. de Poitiers
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women carrying a pregnancy from 30 weeks to 33 weeks either normal or with IUGR,
- Patient without guardianship or curatorship or subordination,
- Patient benefiting from a Social Security scheme
Exclusion Criteria:
- Presence of a fetal malformation,
- Multiple pregnancy,
- Premature rupture of membranes,
- History of bariatric surgery,
- Body mass index (BMI)> 30 kg / m2,
- Patient benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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IUGR
sample of 40 pregnant women affected by intrauterine growth restriction (IUGR) Two referees will perform four successive measurements of the diameter of the right portal vein (RPV) during the same ultrasound examination at the third trimester.
Each operator will qualify the appearance of the right portal vein as normal or collapsed using an evaluation grid, and will independently performe a series of two measurements using the same method.
|
Assessment the intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound
Other Names:
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NORMAL
Ssample of 40 healthy pregnant women Two referees will perform four successive measurements of the diameter of the right portal vein (RPV) during the same ultrasound examination at the third trimester.
Each operator will qualify the appearance of the right portal vein as normal or collapsed using an evaluation grid, and will independently performe a series of two measurements using the same method.
|
Assessment the intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Measurement of the right portal vein diameter
Time Frame: Through study completion, an average of 1 year
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Intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound
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Through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Aspect of the right portal vein diameter
Time Frame: Through study completion, an average of 1 year
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Interoperator reproducibility of the assessment of the aspect, normal or collapsed, of the right portal vein, using an evaluation grid
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Through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020- A01910-39
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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