PreeclampsiaNCT07467226
MATERNAL SERUM CADHERİN-6 AS A PREDİCTOR OF PREECLAMPSİA
An observational study of Preeclampsia and Pregnancy Biomarker, run by Samsun University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Pregnancy Biomarker, Cadherin-6
- What is being tested?
- Maternal serum cadherin-6 measurement
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- 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.
Who may be able to join
- 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
Who cannot join
- Chronic hypertention
- Pregestational diabetes mellitus
- Renal disease
- Multiple pregnancy
- Smoking or alcohol use
- Fetal structural or chromosomal anomalies
- İmmunsuppressive treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
This observational cohort study was retrospectively registered at Clinical Trials.gov.
- Conditions
- Preeclampsia, Pregnancy Biomarker, Cadherin-6
- Being tested
- Maternal serum cadherin-6 measurement
- Keywords
- second trimester screening, preeclampsia, cadherin-6
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal serum cadherin-6 measurementOther
Measurement of maternal serum cadherin-6concentrations using ELİSA in blood samples collected between 15 and 20 weeks of gestation.
| Study group | Role | What they receive |
|---|---|---|
| Preeclampsia Group; Pregnant women who subsequently develop preelampsia during pregnancy | Control Group: Pregnant women with uncomplicated pregnancies matched for gestational age and demographic characteristics. Receives: Other: Maternal serum cadherin-6 measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During pregnancy until delivery
Secondary outcomes (1)
Concentration of maternal serum CDH-6
Measured: within one week of being diagnosed with preeclampsia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Jan 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Collaborators
- Samsun Education and Research Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467226
- Sponsor's protocol ID
- GOKAEK-2024/2/15
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE ROLE OF EARLY SECOND TRİMESTER MATERNAL SERUM CADHERİN-6 LEVELS İNTHE PREDİCTİON OF PREECLAMPSİA
- ClinicalTrials.gov ID
- NCT07467226
- Acronym / sponsor ID
- GOKAEK-2024/2/15
- Conditions
- Preeclampsia, Pregnancy Biomarker, Cadherin-6
- Keywords
- second trimester screening, preeclampsia, cadherin-6
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Collaborators
- Samsun Education and Research Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preeclampsia Group; Pregnant women who subsequently develop preelampsia during pregnancy | – | Other: Maternal serum cadherin-6 measurementControl Group: Pregnant women with uncomplicated pregnancies matched for gestational age and demographic characteristics. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Chronic hypertention
- Pregestational diabetes mellitus
- Renal disease
- Multiple pregnancy
- Smoking or alcohol use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal serum cadherin-6 measurementMeasurement of maternal serum cadherin-6concentrations using ELİSA in blood samples collected between 15 and 20 weeks of gestation. | Other | Preeclampsia Group; Pregnant women who subsequently develop preelampsia during pregnancy |
Primary outcome
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
1 secondary outcome
Concentration of maternal serum CDH-6
Time frame: within one week of being diagnosed with preeclampsia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Pregnancy Biomarker, run by Samsun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.