First Trimester Fetal Thymus Volume May Predict Preeclampsia

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264247
• Other study ID #: 2016/176
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: January 17, 2019

Study information

• Verified date: March 2019
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 17, 2019
• Est. primary completion date: January 1, 2018
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Diagnostic Test:
• routine fetal ultrasonography at 11-14 weeks
routine fetal ultrasonography at 11-14 weeks

Locations

Country	Name	City	State
Turkey	Karadeniz Technical University	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preeclampsia	Hypertension (Sistolik blood pressure >140, diastolic blood pressure >90), Proteinuria (>0.3 g proteinuria in 24 hour collected urine sample)	At least after 10 weeks of initial examination.