Serum Vasohibin, Cardiotrophin, Endocan & Perinatal Outcomes

NCT06416995 | Recruiting

• 1 other identifier: B.10.1.TKH.4.34.H.GP.0.01I 5q
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Gestational Hypertension; Gestational Diabetes; Preterm Birth; Fetal Growth Retardation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

first trimester serum diagnostic test DIAGNOSTIC_TEST

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

Adverse Perinatal Outcome Group; Control Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Gender Eligibility Details: pregnant women
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Ümraniye Eğitim ve Araştırma Hastanesi

Istanbul, Ümraniye, 34764, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Diabetes, Gestational; Premature Birth; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: March 3, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

TU (1)