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

Sponsor
Van Bölge Eğitim ve Araştırma Hastanesi (Other)
Overall Status
Completed
CT.gov ID
NCT04630223
Collaborator
(none)
100
1
7
14.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: endocan in umbilical cord blood

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 Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Comparison of Umbilical Cord Blood Levels of Endocan in Pregnant Females With and Without Intrauterine Growth Retardation
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Sep 1, 2020
Actual Study Completion Date :
Sep 30, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. endocan in umbilical cord blood [just after delivery of fetus at clamping of umbilical cord]

    levels of endothelial cell specific molecule 1 (ng/ml) in umbilical cord blood

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Van Region Education and Training Hospital Van Turkey

Sponsors and Collaborators

  • Van Bölge Eğitim ve Araştırma Hastanesi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
cagdas özgökce, MD, specialist on obstetrics and gynecology, Van Bölge Eğitim ve Araştırma Hastanesi
ClinicalTrials.gov Identifier:
NCT04630223
Other Study ID Numbers:
  • EndocanIUGR
First Posted:
Nov 16, 2020
Last Update Posted:
Nov 16, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by cagdas özgökce, MD, specialist on obstetrics and gynecology, Van Bölge Eğitim ve Araştırma Hastanesi
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2020