Serum Vasohibin, Cardiotrophin, Endocan & Perinatal Outcomes

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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth; Fetal Growth Retardation; Preeclampsia; Gestational Diabetes; Gestational Hypertension
• Intervention / Treatment: Diagnostic test: first trimester serum diagnostic test

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 Type: Observational
• Enrollment (Estimated): 88

Contacts and Locations

Study Locations

• Turkey
  • Ümraniye
    • Istanbul, Ümraniye, Turkey, 34764
      • Recruiting
      • Ümraniye Eğitim ve Araştırma Hastanesi
      • Contact: İbrahim Kale, Associate Professor; Phone Number: 05326473581; Email: dribakale@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with a singleton pregnancy who are between 11 and 14 weeks of gestation, who do not smoke, and do not have any systemic disease.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: first trimester serum 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.	Diagnostic test: first trimester serum diagnostic test; First trimester serum vasohibin-1, vasohibin-2, cardiotropin-1 and endocan concentrations predict adverse perinatal outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Umraniye Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Fetal Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Growth Disorders; Hypertension; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Pre-Eclampsia; Fetal Growth Retardation; Diabetes, Gestational; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: B.10.1.TKH.4.34.H.GP.0.01I 5q

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No