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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04630223
Other study ID # EndocanIUGR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date September 30, 2020

Study information

Verified date November 2020
Source Van Bölge Egitim ve Arastirma Hastanesi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 30, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Van Region Education and Training Hospital Van

Sponsors (1)

Lead Sponsor Collaborator
Van Bölge Egitim ve Arastirma Hastanesi

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Kucukbas GN, Kara O, Yüce D, Uygur D. Maternal plasma endocan levels in intrauterine growth restriction. J Matern Fetal Neonatal Med. 2020 Apr 14:1-6. doi: 10.1080/14767058.2020.1749591. [Epub ahead of print] — View Citation

Lan X, Liu Z. Circulating endocan and preeclampsia: a meta-analysis. Biosci Rep. 2020 Jan 31;40(1). pii: BSR20193219. doi: 10.1042/BSR20193219. — View Citation

Szpera-Gozdziewicz A, Kosicka K, Gozdziewicz T, Krzyscin M, Wirstlein P, Siemiatkowska A, Glowka F, Wender-Ozegowska E, Breborowicz GH. Maternal Serum Endocan Concentration in Pregnancies Complicated by Intrauterine Growth Restriction. Reprod Sci. 2019 Ma — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary endocan in umbilical cord blood levels of endothelial cell specific molecule 1 (ng/ml) in umbilical cord blood just after delivery of fetus at clamping of umbilical cord