MATERNAL SERUM CADHERİN-6 AS A PREDİCTOR OF PREECLAMPSİA

March 11, 2026 updated by: Samsun University

THE ROLE OF EARLY SECOND TRİMESTER MATERNAL SERUM CADHERİN-6 LEVELS İNTHE PREDİCTİON OF PREECLAMPSİA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Measurement of maternal serum cadherin-6concentrations using ELİSA in blood samples collected between 15 and 20 weeks of gestation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: During pregnancy until delivery
During pregnancy until delivery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsun University

Collaborators

Samsun Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOKAEK-2024/2/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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