First Trimester Fetal Thymus Volume May Predict Preeclampsia

NCT04264247 | Completed DMC

• 1 other identifier: 2016/176
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia

Keywords

Fetal thymus volume; Preeclampsia; Screening; Prediction

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

routine fetal ultrasonography at 11-14 weeks DIAGNOSTIC_TEST

routine fetal ultrasonography at 11-14 weeks

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: pregnancy
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• weeks pregnancy with no abnormal ultrasonography evidence.

You may not qualify if:

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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

Location

Related 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.

  PMID: 21308839 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ozlem E Basaran

  Karadeniz technical universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: February 11, 2020
• Study Start: February 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 17, 2019
• Last Updated: February 11, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)