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OpenTrials
Completed

NCT Number: NCT04264247

First Trimester Fetal Thymus Volume May Predict Preeclampsia

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

routine fetal ultrasonography at 11-14 weeks

Diagnostic Test

routine fetal ultrasonography at 11-14 weeks

Primary outcomes

  1. Preeclampsia

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

Is There Any Relationship Between First Trimester (11-14 Weeks of Pregnancy) Fetal Thymus Volume and Preeclampsia? Prospective Cohort Study.

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 11, 2020
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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