First Trimester Fetal Thymus Volume May Predict Preeclampsia

February 8, 2020 updated by: Ozlem Ece BASARAN, Karadeniz Technical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Trabzon, Turkey, 61080
        • Karadeniz Technical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At least after 10 weeks of initial examination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karadeniz Technical University

Investigators

  • Principal Investigator: Ozlem E Basaran, Karadeniz technical universty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2017

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

January 17, 2019

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

February 8, 2020

First Posted (ACTUAL)

February 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 8, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preeclampsia

Clinical Trials on routine fetal ultrasonography at 11-14 weeks

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe