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OpenTrials
Completed

NCT Number: NCT04617964

Reproducibility of the Measurement of the Right Portal Vein Diameter

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

ultrasound

Other

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

Other names: Third trimester ultrasound

Primary outcomes

  1. Measurement of the right portal vein diameter

    Time frame: Through study completion, an average of 1 year

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

Secondary outcomes

  1. Aspect of the right portal vein diameter

    Time frame: Through study completion, an average of 1 year

    Interoperator reproducibility of the assessment of the aspect, normal or collapsed, of the right portal vein, using an evaluation grid

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Intra and Interoperator Reproducibility of the Measurement of the Right Portal Vein Diameter at the Third Trimester Scan

Acronym: PORTALGROWTH1

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 5, 2020
Registry last updated
Oct 12, 2022

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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