Reproducibility of the Measurement of the Right Portal Vein Diameter

NCT04617964 | Completed

• 1 other identifier: 2020- A01910-39
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrauterine Growth Retardation (IUGR)

Keywords

small-for-gestational-age; right portal vein; third-trimester ultrasound; intra and inter-operator reproducibility

Outcome Measures

Primary Outcomes (1)

• Measurement of the right portal vein diameter

  Intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Aspect of the right portal vein diameter

  Through study completion, an average of 1 year

Study Arms (2)

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.

Other: Ultrasound

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.

Other: Ultrasound

Interventions

Ultrasound OTHER

Assessment the intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound

Also known as: Third trimester ultrasound

IUGR; NORMAL

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprise 80 consecutive pregnancies between 30 and 33 weeks, including 40 pregnant women with normal pregnancy, and 40 pregnant women affected by IUGR.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

C.H.U. de Poitiers

Poitiers, 85000, France

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: November 5, 2020
• Study Start: March 8, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)