Serum Vasohibin, Cardiotrophin, Endocan & Perinatal Outcomes

Preterm Birth Clinical Trial

Official title:

Investigation of First Trimester Serum Vasohibin-1, Vasohibin-2, Cardiotrophin-1 and Endocan Concentrations in Predicting Adverse Perinatal Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06416995
• Other study ID #: B.10.1.TKH.4.34.H.GP.0.01I 5q
• Status: Recruiting
• Start date: March 3, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Fetal Growth Retardation
• Gestational Diabetes
• Gestational Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Preeclampsia
• Premature Birth
• Preterm Birth

Intervention

Diagnostic Test:
• first trimester serum diagnostic test
First trimester serum vasohibin-1, vasohibin-2, cardiotropin-1 and endocan concentrations predict adverse perinatal outcomes

Locations

Country	Name	City	State
Turkey	Ümraniye Egitim ve Arastirma Hastanesi	Istanbul	Ümraniye

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability of serum vasohibin-1, vasohibin-2, cardiotropin-1 and endocan concentrations in predicting adverse perinatal outcomes	Usability of serum vasohibin-1, vasohibin-2, cardiotropin-1 and endocan concentrations in predicting adverse perinatal outcomes	1 year