Clinical trial NCT04264247: First Trimester Fetal Thymus Volume May Predict Preeclampsia
Official title: Is There Any Relationship Between First Trimester (11-14 Weeks of Pregnancy) Fetal Thymus Volume and Preeclampsia? Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: Fetal thymus volume
Preeclampsia
Screening
Prediction
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 pregnancy women at 11-14 week of gestation were included in the study in the Obstetrics Department of Obstetrics and Gynecology of Medicine Faculty of Karadeniz Technical University, Medical Faculty of Medicine.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Preeclampsia
timeFrame: At least after 10 weeks of initial examination.
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
affiliation: Karadeniz technical universty
name: Ozlem E Basaran
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohamed N, Eviston DP, Quinton AE, Benzie RJ, Kirby AC, Peek MJ, Nanan RK. Smaller fetal thymuses in pre-eclampsia: a prospective cross-sectional study. Ultrasound Obstet Gynecol. 2011 Apr;37(4):410-5. doi: 10.1002/uog.8953. Epub 2011 Mar 7.