## Protocol Section
### Identification Module
**NCT ID:** NCT06416995

**Brief Title:** Serum Vasohibin, Cardiotrophin, Endocan & Perinatal Outcomes

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

#### Organization Study ID Info
**ID:** B.10.1.TKH.4.34.H.GP.0.01I 5q
#### Organization
**Class:** OTHER_GOV
**Full Name:** Umraniye Education and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-11-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-03-03

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Umraniye Education and Research Hospital

#### Responsible Party

**Investigator Affiliation:** Umraniye Education and Research Hospital

**Investigator Full Name:** ibrahim kale

**Investigator Title:** Associate professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Preeclampsia

- Gestational Hypertension

- Gestational Diabetes

- Preterm Birth

- Fetal Growth Retardation

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 88

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: first trimester serum diagnostic test

**Label:** Control Group

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: first trimester serum diagnostic test

**Label:** Adverse Perinatal Outcome Group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Adverse Perinatal Outcome Group

- Control Group

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

**Name:** first trimester serum diagnostic test

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Usability of serum vasohibin-1, vasohibin-2, cardiotropin-1 and endocan concentrations in predicting adverse perinatal outcomes

**Measure:** Usability of serum vasohibin-1, vasohibin-2, cardiotropin-1 and endocan concentrations in predicting adverse perinatal outcomes

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** 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

**Gender Based:** True

**Gender Description:** pregnant women

**Maximum Age:** 39 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Istanbul

**Contacts:**

***Contact 1:***

- **Email:** dribakale@hotmail.com

- **Name:** İbrahim Kale, Associate Professor

- **Phone:** 05326473581

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Ümraniye Eğitim ve Araştırma Hastanesi

**State:** Ümraniye

**Status:** RECRUITING

**Zip:** 34764

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006973

- Term: Hypertension

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000007752

- Term: Obstetric Labor, Premature

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000005315

- Term: Fetal Diseases

- ID: D000006130

- Term: Growth Disorders

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M19012

- Name: Diabetes, Gestational

- Relevance: HIGH

- As Found: Gestational Diabetes

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M14106

- Name: Pre-Eclampsia

- Relevance: HIGH

- As Found: Preeclampsia

- ID: M25869

- Name: Premature Birth

- Relevance: HIGH

- As Found: Preterm Birth

- ID: M25635

- Name: Hypertension, Pregnancy-Induced

- Relevance: HIGH

- As Found: Gestational Hypertension

- ID: M8447

- Name: Fetal Growth Retardation

- Relevance: HIGH

- As Found: Fetal Growth Retardation

- ID: M7633

- Name: Eclampsia

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10772

- Name: Obstetric Labor, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8445

- Name: Fetal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9230

- Name: Growth Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T2019

- Name: Eclampsia

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016640

- Term: Diabetes, Gestational

- ID: D000011225

- Term: Pre-Eclampsia

- ID: D000047928

- Term: Premature Birth

- ID: D000046110

- Term: Hypertension, Pregnancy-Induced

- ID: D000005317

- Term: Fetal Growth Retardation

### Misc Info Module

- Version Holder: 2024-05-31
