Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05328453 |
Other study ID # |
2016/181 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 1, 2016 |
Est. completion date |
March 1, 2017 |
Study information
Verified date |
April 2022 |
Source |
Karadeniz Technical University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.