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NCT Number: NCT07467226

MATERNAL SERUM CADHERİN-6 AS A PREDİCTOR 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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Canan Soyer Çalışkan

Samsun, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Concentration of maternal serum CDH-6

    Time frame: within one week of being diagnosed with preeclampsia

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Collaborators

  • Samsun Education and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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