MATERNAL SERUM CADHERİN-6 AS A PREDİCTOR OF PREECLAMPSİA | NCT07467226

Studies
MATERNAL SERUM CADHERİN-6 AS A PREDİCTOR OF PREECLAMPSİA

NCT07467226

Sponsor

Samsun University

Status

Completed

Last Update Posted

Mar 13, 2026Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Preeclampsia
Pregnancy Biomarker
Cadherin-6

Interventions

Maternal serum cadherin-6 measurement

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Dec 30, 2024Actual

Completion Date

Dec 30, 2024Actual

First Submitted Date

Mar 9, 2026

First Submission Date that Met QC Criteria

Mar 9, 2026

First Posted Date

Mar 12, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2026

Last Update Posted Date

Mar 13, 2026Actual

Name	Class
Samsun Education and Research Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Preeclampsia is a pregnancy-specific hypertensive disorder that remains one of the leading causes of maternal and perinatal morbidity and mortality worldwide. Despite extensive research, reliable biomarkers for the early prediction of preeclampsia are still limited. Early identification of pregnancies at risk is clinically important because preventive interventions such as low-dose aspirin therapy may reduce the incidence and severity of the disease.

Cadherin-6 (CDH-6) is a calcium-dependent cell adhesion molecule involved in trophoblast invasion and placental development. Abnormal trophoblast differentiation and impaired spiral artery remodeling are key mechanisms implicated in the pathophysiology of preeclampsia. Therefore, molecules involved in placental cell adhesion may have potential as predictive biomarkers for this condition.

This prospective observational cohort study aims to investigate whether maternal serum CDH-6 levels measured during the early second trimester of pregnancy (15-20 weeks of gestation) can predict the subsequent development of preeclampsia. Maternal blood samples collected during routine antenatal screening will be analyzed using an enzyme-linked immunosorbent assay (ELISA) to determine CDH-6 concentrations. Pregnancy outcomes will be evaluated and compared between women who develop preeclampsia and those with uncomplicated pregnancies.

The findings of this study may provide evidence regarding the predictive value of CDH-6 as an early biomarker for preeclampsia and contribute to improved risk stratification and earlier preventive strategies in pregnancy.

Detailed Description

This observational cohort study was retrospectively registered at Clinical Trials.gov.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Preeclampsia Group; Pregnant women who subsequently develop preelampsia during pregnancy		Control Group: Pregnant women with uncomplicated pregnancies matched for gestational age and demographic characteristics.	Other: Maternal serum cadherin-6 measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Maternal serum cadherin-6 measurement	Other	Measurement of maternal serum cadherin-6concentrations using ELİSA in blood samples collected between 15 and 20 weeks of gestation.	Preeclampsia Group; Pregnant women who subsequently develop preelampsia during pregnancy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Development of preeclampsia, Diagnosis of preeclampsia defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg after 20 weeks of gestation accompanied by proteinuria or signs of end-organ dysfunction.		During pregnancy until delivery

Secondary Outcomes

Measure	Description	Time Frame
Concentration of maternal serum CDH-6		within one week of being diagnosed with preeclampsia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women aged 18-40 years
Singleton pregnancy
Gestational age between 15 and 20 weeks confirmed by first-trimester ultrasound
Availability of stored maternal serum samples
Written informed consent

Exclusion Criteria:

Chronic hypertention
Pregestational diabetes mellitus
Renal disease
Multiple pregnancy
Smoking or alcohol use
Fetal structural or chromosomal anomalies
İmmunsuppressive treatment

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Peripheral venous blood samples will be collected between 15-20 weeks of gestation. Serum samples will be separated by centrifugation and stored at -80 ˚C until analysis.Serum concentrations of human cadherin-6 will be measured using an ELİSA method.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Canan Soyer Çalışkan		Samsun			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

serum, peripheral venous blood samples will be collected between 15 and 20 weeks of gestation. serum samples will be separated by centrifugation and stored at - 80 C until analysis. Serum concentrations of humon cadherin-6will be measured using an ELİSA method.