First Trimester Fetal Thymus Volume May Predict Preeclampsia

Completed

• Conditions: Preeclampsia

• Registration Number: NCT04264247
• Lead Sponsor: Karadeniz Technical University

Brief Summary

The exact etiology of preeclampsia remains unclear but is known to involve immunological 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 fetal thymus volume on ultrasound and preeclampsia by adding the 3-dimensional measurement of thymus volume to the routine fetal ultrasound scan at 11-14 week of gestation.

Investigators performed a prospective clinical study in 100 pregnant women in their first 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, CRL 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 preeclampsia and without preeclampsia were compared. The ability of the thymus volume to predict the preeclampsia was tested using binary logistic regression analysis. P value \<0.05 was considered statistically significant.

Detailed Description

The exact etiology of preeclampsia remains unclear but is known to involve immunological 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 fetal thymus volume on ultrasound and preeclampsia by adding the 3-dimensional measurement of thymus volume to the routine fetal ultrasound scan at 11-14 week of gestation.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2018-01-01
• Study Completion: 2019-01-17
• Status Verified: 2019-03
• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2020-02-08
• Last Update Submitted: 2020-02-08
• Study First Posted: 2020-02-11
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• 11-14 weeks pregnancy with no abnormal ultrasonography evidence.

Exclusion Criteria

Any history of obstetric complications Chronic hypertension Diabetes mellitus Infectious or autoimmune disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preeclampsia	At least after 10 weeks of initial examination.	Hypertension (Sistolik blood pressure \>140, diastolic blood pressure \>90), Proteinuria (\>0.3 g proteinuria in 24 hour collected urine sample)

Trial Locations

Locations (1)

Karadeniz Technical University; 🇹🇷 Trabzon, Turkey