Serum Vasohibin, Cardiotrophin, Endocan & Perinatal Outcomes

NCT ID: NCT06416995

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-03

Study Completion Date

2024-12-30

Brief Summary

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Investigation of the relationship between maternal serum vasohibin-1, vasohibin-2, cardiotrophin -1 and endocan concentrations at the 11th and 14th weeks of gestation and adverse perinatal outcomes.

Detailed Description

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Previous animal model studies in the literature have shown that vasohibin-1 released in endothelial cells inhibits angiogenesis, while vasohibin-2 stimulates angiogenesis. Additionally, immunohistochemical studies have shown that vasohibin-2 plays a role in the cellular fusion of trophoblasts in the placenta to form syncytiotrophoblasts.

Studies in the literature have shown that cardiotrophin-1 is expressed in cardiac myocytes and vascular endothelial cells and stimulates the synthesis and secretion of endothelin-1 in endothelial cells through the gp130 signaling pathway. Since endothelin 1 plays an important role in the regulation of vascular tone, cardiotrophin-1 can be considered to act as an endothelium-derived biological factor, possibly involved in the regulation of vascular tone under normal physiological conditions or secondary to pathological processes.

Studies in the literature have shown that maternal serum endocan levels are higher in pregnant women whose pregnancies were complicated by preeclampsia than in normotensive pregnant women, and that the endocan molecule may be effective in the etiopathogenesis of preeclampsia, especially if it develops early.

In the light of this above-mentioned information, we aim to investigate whether serum vasohibin-1, vasohibin-2, cardiotrophin-1 and endocan concentrations measured during the 11th to 14th weeks of pregnancy can be used to predict preeclampsia, gestational hypertension, fetal growth restriction, preterm birth and gestational diabetes mellitus.

Conditions

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Preeclampsia Gestational Hypertension Gestational Diabetes Preterm Birth Fetal Growth Retardation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Group

Pregnant women who do not have any pregestational disease, who gave a blood sample in the first trimester for the study, who did not develop any pregnancy-related disease during their pregnancy, and who gave birth at term.

first trimester serum diagnostic test

Intervention Type DIAGNOSTIC_TEST

First trimester serum vasohibin-1, vasohibin-2, cardiotropin-1 and endocan concentrations predict adverse perinatal outcomes

Adverse Perinatal Outcome Group

Pregnant women who do not have any pregestational disease and who gave a blood sample in the first trimester for the study and who develop preeclampsia, gestational hypertension, preterm birth, fetal growth restriction, and gestational diabetes mellitus in the later weeks of pregnancy.

first trimester serum diagnostic test

Intervention Type DIAGNOSTIC_TEST

First trimester serum vasohibin-1, vasohibin-2, cardiotropin-1 and endocan concentrations predict adverse perinatal outcomes

Interventions

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first trimester serum diagnostic test

First trimester serum vasohibin-1, vasohibin-2, cardiotropin-1 and endocan concentrations predict adverse perinatal outcomes

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Those who had the first-trimester screening test between 11 and 14 weeks of pregnancy and are in the low-risk group
* Those with singleton pregnancy
* Those who did not conceive pregnancy with assisted reproductive treatment methods
* Those who do not have any pregestational diseases
* Those who do not have any uterine anomalies

Exclusion Criteria

* Smokers
* Those who are in the high-risk group with the first trimester screening test
* Those with multiple pregnancies
* Those who conceive with assisted reproductive treatment methods
* Those who had any disease before pregnancy
* Those who have any uterine anomalies
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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ibrahim kale

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ümraniye Eğitim ve Araştırma Hastanesi

Istanbul, Ümraniye, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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İbrahim Kale, Associate Professor

Role: primary

05326473581

Other Identifiers

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B.10.1.TKH.4.34.H.GP.0.01I 5q

Identifier Type: -

Identifier Source: org_study_id

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