Sonographic 3D Measurement of Fetal Thymus May be Used to Predict the Small Baby in Pregnancy.

The exact etiology of intrauterine growth restriction (IUGR) remains unclear but is known to involve immunologic/infectious factors. The thymus is one of the main organs involved in the development of the fetal immune system. The aim of this study was to explore the association between 3D fetal thymus volume (VOCAL) on ultrasound and intrauterine growth restiction by adding the 3-dimensional measurement of thymus volume to the routine fetal ultrasound scan at 15-24 week of gestation.

Investigators performed a prospective clinical study in 100 pregnant women in their second trimester of pregnancy who attended the Fetal Medicine Unit of the Medicine Faculty of Karadeniz Technical University during the study period. Maternal age, gravida, para, BMI, blood pressure, gestational age, BPD, FL ,AC, EFW and fetal timus volume measured with VOCAL programme are recorded. For all patients routine clinical and ultrasound examinations were performed during pregnancy. Gestational age at birth, way of birth and newborn birthweight were recorded. The results were statistically compared in the SPSS 13.0 program. Student-t test and chi-square test were used for statistical analysis. ROC curve analysis was used for limit values. The data of patients with IUGR and without IUGR were compared. The ability of the thymus volume to predict the IUGR was tested using binary logistic regression analysis. P value <0.05 was considered statistically significant.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

Female

Study type

Observational

About this study

A signed informed consent form for voluntary participation in the study was provided by all the women. A record was made for each patient of age, gravida, parity, body mass index (BMI), and sonographic measurements of biparietal diameter (BPD), abdominal circumference (AC), femur length (FL), and estimated fetal weight (EFW).

3D Fetal thymus volume (TV) was measured by using a VOLUSON E-10 ultrasonography device, by a single researcher experienced in the use of obstetric ultrasound with a transabdominal volumetric probe. The fetal thymus, transverse section of the fetal chest, and the 3 vessel sections were visualised, then the 3D US modality was activated and the thymus volume was obtained immediately with the same probe.

All cases were followed up in terms of pregnancy complications (IUGR development) until delivery.

Who can participate

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

Inclusion criteria

Aged 18-35 years,
Who presented at the polyclinic for routine antenatal follow-up at 15-24 weeks
Had no complaints.
Had normal renal, hepatic, and thyroid functions test results.

Exclusion criteria

Any known endocrinopathy,
systemic disease,
collagen disorder,
hypercholesterolemia,
hemoglobinopathy
history of neoplasm,
current or previous cardiovascular disease,
the use of any drugs within the 3 months before the pregnancy,
multiple pregnancy,
current smoking,
abnormal renal, hepatic, or thyroid function test results,
the presence of any findings of fetal chromasomal or structural anomaly,
refusal to participate in the study.

Treatment and study plan

Fetal prenatal ultrasonographic evaluation.

Diagnostic Test

Routine fetal ultrasonography at 15-24 weeks. All sonographic measurements including 3D fetal thymus calculation was measured.

Primary outcomes

IUGR development.

Time frame: One year period.

IUGR was accepted as EFW below the 10th percentile according to BPD, FL, and AC

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

Prenatal Sonographic 3D VOCAL Thymic Volume Calculation May Predict Intrauterine Growth Restriction

Acronym: IUGR

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Apr 14, 2022
Registry last updated: Apr 14, 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.

Published trials that share one or more normalized conditions with this study.

Completed