Serum Vasohibin, Cardiotrophin, Endocan & Perinatal Outcomes

Recruiting

• Conditions: Gestational Hypertension; Preterm Birth; Preeclampsia; Fetal Growth Retardation; Gestational Diabetes
• Interventions: Diagnostic Test: first trimester serum diagnostic test

• Registration Number: NCT06416995
• Lead Sponsor: Umraniye Education and Research Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-03-03
• Status Verified: 2024-05
• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-13
• Last Update Submitted: 2024-05-13
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 88

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adverse Perinatal Outcome Group	first trimester serum diagnostic test	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.
Control Group	first trimester serum diagnostic test	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.

Primary Outcome Measures

Name	Time	Method
Usability of serum vasohibin-1, vasohibin-2, cardiotropin-1 and endocan concentrations in predicting adverse perinatal outcomes	1 year	Usability of serum vasohibin-1, vasohibin-2, cardiotropin-1 and endocan concentrations in predicting adverse perinatal outcomes

Trial Locations

Locations (1)

Ümraniye Eğitim ve Araştırma Hastanesi; 🇹🇷 Istanbul, Ümraniye, Turkey