Intrauterine RetardationNCT04630223
Levels of Endocan in Umbilical Cord Blood Samples of Pregnant Females With Intrauterine Growth Retardation
An observational study of Intrauterine Retardation, run by Van Bölge Eğitim ve Araştırma Hastanesi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Retardation
- What is being tested?
- endocan in umbilical cord blood
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant females attending outpatient clinics of obstetrics in a tertiary hospital.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Region Education and Training Hospital
Van
About this study
Official title: 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.
Read the 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.
- Conditions
- Intrauterine Retardation
- Being tested
- endocan in umbilical cord blood
- Keywords
- intrauterine growth retardation, umbilical cord blood, proteoglycans, pregnancy outcomes
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endocan in umbilical cord bloodDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: endocan in umbilical cord blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
endocan in umbilical cord blood
levels of endothelial cell specific molecule 1 (ng/ml) in umbilical cord blood
Measured: just after delivery of fetus at clamping of umbilical cord
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Mar 2020
- Primary completion1 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intrauterine RetardationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Van Bölge Eğitim ve Araştırma Hastanesi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, cagdas özgökce, Van Bölge Eğitim ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630223
- Sponsor's protocol ID
- EndocanIUGR
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Medical data of the participants are going o be shared if it is requested.
Publications
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.
PubMed 32290736Lan X, Liu Z. Circulating endocan and preeclampsia: a meta-analysis. Biosci Rep. 2020 Jan 31;40(1):BSR20193219. doi: 10.1042/BSR20193219.
PubMed 31854443Szpera-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.
PubMed 29742984
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Umbilical Cord Blood Levels of Endocan in Pregnant Females With and Without Intrauterine Growth Retardation
- ClinicalTrials.gov ID
- NCT04630223
- Acronym / sponsor ID
- EndocanIUGR
- Conditions
- Intrauterine Retardation
- Keywords
- intrauterine growth retardation, umbilical cord blood, proteoglycans, pregnancy outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Van Bölge Eğitim ve Araştırma HastanesiOther government
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intrauterine growth retardation | – | Diagnostic Test: endocan in umbilical cord bloodBlood 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. |
| healthy fetuses | – | Diagnostic Test: endocan in umbilical cord bloodBlood 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant females attending outpatient clinics of obstetrics in a tertiary hospital.
Key inclusion criteria (6 listed)
- consent to participate study
- detection of intrauterine growth retardation during follow up of pregnancy
- consent to participate study
- absence of intrauterine growth retardation during follow up of pregnancy
Key exclusion criteria (7 listed)
- multiple pregnancy
- presence of major developmental anomalies of fetuses
- detection of chromosomal anomalies
- malnourished mothers
- vegetarian diet of mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endocan in umbilical cord bloodAfter 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. | Diagnostic test | healthy fetuses, intrauterine growth retardation |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Results publication: PubMed 32290736Kucukbas 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.
- Results publication: PubMed 31854443Lan X, Liu Z. Circulating endocan and preeclampsia: a meta-analysis. Biosci Rep. 2020 Jan 31;40(1):BSR20193219. doi: 10.1042/BSR20193219.
- Results publication: PubMed 29742984Szpera-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.
- Individual participant dataSharing planned: No. Medical data of the participants are going o be shared if it is requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Retardation, run by Van Bölge Eğitim ve Araştırma Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endocan in umbilical cord blood (time frame: just after delivery of fetus at clamping of umbilical cord). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04630223, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.