First Trimester Fetal Thymus Volume May Predict Preeclampsia

NCT ID: NCT04264247

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2019-01-17

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.

Conditions

Preeclampsia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

routine fetal ultrasonography at 11-14 weeks

routine fetal ultrasonography at 11-14 weeks

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karadeniz Technical University

OTHER

Sponsor Role: lead

Responsible Party

Ozlem Ece BASARAN

research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ozlem E Basaran

Role: PRINCIPAL_INVESTIGATOR

Karadeniz technical universty

Locations

Karadeniz Technical University

Trabzon, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 21308839 (View on PubMed)

Other Identifiers

2016/176

Identifier Type: -

Identifier Source: org_study_id