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

Sponsor

Karadeniz Technical University (Other)

Overall Status

Completed

CT.gov ID

NCT05328453

Collaborator

(none)

100

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intrauterine Growth Restriction	Diagnostic Test: Fetal prenatal ultrasonographic evaluation.

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.

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Pregnant women at 15-24 gestation. Routine fetal ultrasonography at 15-24 weeks. All sonographic measurements including 3D fetal thymus calculation was measured.	Diagnostic Test: Fetal prenatal ultrasonographic evaluation. Routine fetal ultrasonography at 15-24 weeks. All sonographic measurements including 3D fetal thymus calculation was measured.

Arm

Intervention/Treatment

Pregnant women at 15-24 gestation.

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

Diagnostic Test: Fetal prenatal ultrasonographic evaluation.

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

Outcome Measures

Primary Outcome Measures

IUGR development. [One year period.]
IUGR was accepted as EFW below the 10th percentile according to BPD, FL, and AC

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Karadeniz Technical University

Investigators

Study Chair: Suleyman Guven, Prof, Karadeniz Technical University Faculty of Medicine Department of Obs and Gyn

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suleyman Guven, Prof. Dr., Karadeniz Technical University

ClinicalTrials.gov Identifier:

NCT05328453

Other Study ID Numbers:

2016/181

First Posted:

Apr 14, 2022

Last Update Posted:

Apr 14, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fetal Growth Retardation

Study Results

No Results Posted as of Apr 14, 2022