- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07745036
Role of Progesterone Membrane Receptors in the Pathogenesis of Preeclampsia
Investigation of Progesterone Membrane Receptor Expression in Placental Tissue of Women With Preeclampsia and Their Potential Role in the Pathogenesis of Preeclampsia
Preeclampsia is a pregnancy-specific hypertensive disorder and remains a leading cause of maternal and perinatal morbidity and mortality worldwide. Although abnormal placentation, impaired trophoblast invasion, endothelial dysfunction, and immune dysregulation have been implicated in its pathogenesis, the underlying molecular mechanisms are not fully understood.
Progesterone plays a critical role in the maintenance of pregnancy through both classical nuclear receptors and membrane-associated progesterone receptors. Emerging evidence suggests that progesterone membrane receptors, including progesterone receptor membrane component 1 (PGRMC1), progesterone receptor membrane component 2 (PGRMC2), and members of the progestin and adipoQ receptor (PAQR) family, may regulate trophoblast invasion, placental development, and inflammatory responses.
This study aims to compare the placental expression levels of PGRMC1, PGRMC2, and PAQR family receptors between women with preeclampsia and healthy pregnant controls and to investigate their potential role in the pathophysiology of preeclampsia.
Study Overview
Status
Conditions
Detailed Description
Preeclampsia affects approximately 3-8% of pregnancies and is characterized by new-onset hypertension and multisystem involvement after 20 weeks of gestation. Despite extensive research, its molecular pathogenesis remains incompletely understood.
Progesterone is essential for successful pregnancy maintenance and contributes to uterine quiescence, trophoblast function, and maternal-fetal immune tolerance. In addition to classical genomic signaling pathways, progesterone exerts rapid non-genomic effects through membrane-associated receptors, including PGRMC1, PGRMC2, and PAQR family members.
Recent studies have demonstrated that these receptors are involved in trophoblast invasion, angiogenesis, endothelial function, and inflammatory regulation. Alterations in their expression may contribute to abnormal placentation and endothelial dysfunction observed in preeclampsia.
The present study will evaluate placental expression levels of PGRMC1, PGRMC2, and selected PAQR family receptors in women with preeclampsia and healthy controls. Placental tissue obtained after delivery will undergo immunohistochemical and mRNA expression analyses. The findings may improve understanding of the molecular mechanisms underlying preeclampsia and identify potential biomarkers or therapeutic targets.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Canan Soyer Çalışkan, MD, Associate Professor
- Phone Number: + 90 532 203 55 38
- Email: canan.caliskan@samsun.edu.tr
Study Contact Backup
- Name: Canan Soyer Çalışkan, MD, Associate Professor
- Phone Number: 90 532 203 55 90 362 311 15 40
- Email: canan.caliskan@samsun.edu.tr
Study Locations
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Samsun, Turkey (Türkiye)
- Recruiting
- Samsun University Faculty of Medicine Samsun Training and Research Hospital
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Contact:
- Canan SOYER ÇALIŞKAN, MD, Associated Professor
- Phone Number: +90 532 203 55 38
- Email: canan.caliskan@samsun.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Preeclampsia Group Pregnant women diagnosed with preeclampsia who provide placental tissue samples following delivery.
Healthy Control Group Normotensive pregnant women providing placental tissue samples following delivery.
Description
Inclusion Criteria:
Preeclampsia Group Women aged 18-45 years Singleton pregnancy Diagnosis of preeclampsia according to ACOG criteria Delivery at the study center Written informed consent Control Group Women aged 18-45 years Singleton pregnancy Normotensive healthy pregnancy Delivery at the study center Written informed consent
Exclusion Criteria:
Age <18 or >45 years Multiple gestation Fetal structural or chromosomal anomalies Chronic hypertension Pre-existing diabetes mellitus Autoimmune diseases Renal disease Other major systemic disorders
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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preeclampsia group
Preeclampsia group
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Control Group
Healty Control Group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Placental expression levels of progesterone membrane receptors (PGRMC1, PGRMC2, and PAQR family receptors)
Time Frame: At delivery
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Quantitative comparison of placental receptor expression levels between preeclamptic and healthy pregnancies using immunohistochemical and mRNA-based analyses.
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At delivery
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Canan Soyer Çalışkan, MD, Associate Professor, Samsun University Faculty of Medicine, Samsun Training and Research Hospital
- Study Chair: Soyer Çalışkan, Samsun University Faculty of Medicine, Samsun Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMUK2025/311
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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