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

NCT05328453 | Completed

• 1 other identifier: 2016/181
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (1)

• IUGR development.

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

  One year period.

Study Arms (1)

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.

Interventions

Fetal prenatal ultrasonographic evaluation. DIAGNOSTIC_TEST

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

Pregnant women at 15-24 gestation.

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This prospective cohort study included 100 women with a single pregnancy who presented at the current clinic in one year period and had no risk factors for high-risk pregnancy in the second trimester screening for anomalies.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karadeniz Technical University: lead

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

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

Study Officials

• Suleyman Guven, Prof

  Karadeniz Technical University Faculty of Medicine Department of Obs and Gyn

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: April 14, 2022
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 14, 2022

Record last verified: 2022-04