- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Canan Soyer Çalışkan, MD, Associate Professor
- Telefonnummer: + 90 532 203 55 38
- E-mail: canan.caliskan@samsun.edu.tr
Undersøgelse Kontakt Backup
- Navn: Canan Soyer Çalışkan, MD, Associate Professor
- Telefonnummer: 90 532 203 55 90 362 311 15 40
- E-mail: canan.caliskan@samsun.edu.tr
Studiesteder
-
-
-
Samsun, Tyrkiet (Türkiye)
- Rekruttering
- Samsun University Faculty of Medicine Samsun Training and Research Hospital
-
Kontakt:
- Canan SOYER ÇALIŞKAN, MD, Associated Professor
- Telefonnummer: +90 532 203 55 38
- E-mail: canan.caliskan@samsun.edu.tr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
preeclampsia group
Preeclampsia group
|
|
Control Group
Healty Control Group
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Placental expression levels of progesterone membrane receptors (PGRMC1, PGRMC2, and PAQR family receptors)
Tidsramme: At delivery
|
Quantitative comparison of placental receptor expression levels between preeclamptic and healthy pregnancies using immunohistochemical and mRNA-based analyses.
|
At delivery
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Canan Soyer Çalışkan, MD, Associate Professor, Samsun University Faculty of Medicine, Samsun Training and Research Hospital
- Studiestol: Soyer Çalışkan, Samsun University Faculty of Medicine, Samsun Training and Research Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OMUK2025/311
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .