Levels of Endocan in Umbilical Cord Blood Samples of Pregnant Females With Intrauterine Growth Retardation

November 9, 2020 updated by: cagdas özgökce, Van Bölge Eğitim ve Araştırma Hastanesi

Comparison of Umbilical Cord Blood Levels of Endocan in Pregnant Females With and Without Intrauterine Growth Retardation

As a proteoglycan secreted from endothelial cells, expression, and secretion of endocan increases in the endothelium of several tissues secondary to inflammation. It can be regarded as an indicator of endothelial damage. Besides, it is both a target and a modulator of the vascular endothelial growth factor (VEGF) signaling pathway. Considering its action mechanisms, it can provide information about angiogenesis, inflammation, and vascular permeability.

It is known that intrauterine growth retardation mainly occurs as a result of endothelial dysfunction and abnormal angiogenesis in the placenta. In previous studies, maternal serum endocan levels have also been shown to be increased in cases of preeclampsia, which is mainly characterized by placental dysfunction.So, we hypothesize that there may be an association between endocan levels and intrauterine growth retardation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endocan is a proteoglycan that is closely associated with inflammation. Its levels increase in association with the severity of endothelial damage. Endothelial dysfunction and abnormal angiogenesis in the placental tissues are the main pathophysiological mechanisms leading to intrauterine growth retardation.

It has been known that there was a significant association between maternal serum levels of endocan and preeclampsia. In cases with preeclampsia, increased serum levels of endocan in maternal blood samples has been reported.

Intrauterine growth retardation is a situation in which endothelial dysfunction and abnormal angiogenesis are the leading disturbances. In fetuses with intrauterine growth retardation, a hypoxic environment secondary to uteroplacental insufficiency. In previous studies, increased levels of endocan in maternal blood samples have been shown. Although maternal blood can be a good reflector of situations both in fetuses and their mothers, measurement of endocan in umbilical cord blood samples may better represent the pathology in fetuses.

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
      • Van, Turkey
        • Van Region Education and Training Hospital

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

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant females attending outpatient clinics of obstetrics in a tertiary hospital.

Description

Inclusion Criteria:

For "intrauterine growth retardation" group:

  • consent to participate study
  • detection of intrauterine growth retardation during follow up of pregnancy

For "healthy fetuses" group:

  • consent to participate study
  • absence of intrauterine growth retardation during follow up of pregnancy

Exclusion Criteria:

  • multiple pregnancy
  • presence of major developmental anomalies of fetuses
  • detection of chromosomal anomalies
  • malnourished mothers
  • vegetarian diet of mothers
  • use of cigarette and alcohol during pregnancy
  • previous history of stillbirths

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
intrauterine growth retardation
Blood samples are going to be taken from the umbilical cord of the fetuses. Levels of endocan (endothelial cell specific molecule 1) in the samples of umbilical cord blood are going to be measured using human endocan ELISA kits.
Diagnostic test: endocan in umbilical cord blood
After taking blood samples from the umbilical cord, centrifugation is applied to all samples for 15 minutes at 1000 rpm. The serum samples with specific identification numbers are going to be stored at -80 °C. After completing the study group, all serum samples will be analyzed using human endocan ELISA kit for the measurement of endocan levels.
healthy fetuses
Blood samples are going to be taken from the umbilical cord of healthy fetuses without intrauterine growth retardation. Levels of endocan (endothelial cell specific molecule 1) in the samples of umbilical cord blood are going to be measured using human endocan ELISA kits.
Diagnostic test: endocan in umbilical cord blood
After taking blood samples from the umbilical cord, centrifugation is applied to all samples for 15 minutes at 1000 rpm. The serum samples with specific identification numbers are going to be stored at -80 °C. After completing the study group, all serum samples will be analyzed using human endocan ELISA kit for the measurement of endocan levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endocan in umbilical cord blood
Time Frame: just after delivery of fetus at clamping of umbilical cord
levels of endothelial cell specific molecule 1 (ng/ml) in umbilical cord blood
just after delivery of fetus at clamping of umbilical cord

Collaborators and Investigators

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

Sponsor

Van Bölge Eğitim ve Araştırma Hastanesi

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)

March 1, 2020

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

November 9, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

November 16, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EndocanIUGR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Medical data of the participants are going o be shared if it is requested.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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