Reproducibility of the Measurement of the Right Portal Vein Diameter

Intrauterine Growth Retardation (IUGR) Clinical Trial

— PORTALGROWTH1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04617964
• Other study ID #: 2020- A01910-39
• Status: Completed
• Start date: March 8, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: October 2022
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Retardation (IUGR)

Intervention

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

Locations

Country	Name	City	State
France	C.H.U. de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Aspect of the right portal vein diameter	Interoperator reproducibility of the assessment of the aspect, normal or collapsed, of the right portal vein, using an evaluation grid	Through study completion, an average of 1 year