Ignite Creation Date:
2024-05-06 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05328453
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2022-02-10
Brief Title:
Sonographic 3D Measurement of Fetal Thymus May be Used to Predict the Small Baby in Pregnancy
Sponsor:
Karadeniz Technical University
Organization:
Karadeniz Technical University
Study Overview
Official Title:
Prenatal Sonographic 3D VOCAL Thymic Volume Calculation May Predict Intrauterine Growth Restriction
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IUGR
Brief Summary:
The exact etiology of intrauterine growth restriction IUGR remains unclear but is known to involve immunologicinfectious 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 130 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 005 was considered statistically significant
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 130 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 005 was considered statistically significant
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None