NCT04630223

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

November 9, 2020

Last Update Submit

November 9, 2020

Conditions

Keywords

intrauterine growth retardationumbilical cord bloodproteoglycanspregnancy outcomes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

Interventions

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 fetusesintrauterine growth retardation

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale pregnants
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Region Education and Training Hospital

Van, Turkey (Türkiye)

Location

Related Publications (3)

  • Kucukbas GN, Kara O, Yuce D, Uygur D. Maternal plasma endocan levels in intrauterine growth restriction. J Matern Fetal Neonatal Med. 2022 Apr;35(7):1295-1300. doi: 10.1080/14767058.2020.1749591. Epub 2020 Apr 14.

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

  • 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 Mar;26(3):370-376. doi: 10.1177/1933719118773480. Epub 2018 May 9.

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, specialist on obstetrics and gynecology

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 16, 2020

Study Start

March 1, 2020

Primary Completion

September 1, 2020

Study Completion

September 30, 2020

Last Updated

November 16, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

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

Locations