Placental Expression of EG-VEGF and Its PROKR1 and PROKR2 Receptors in Preeclampsia Patients.

Completed

• Conditions: Preeclampsia
• Interventions: Biological: Placenta pathological examination

• Registration Number: NCT04846686
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

The pathophysiology of preeclampsia (PE) is thought to be endothelial dysfunction responsible for the maternal signs of de novo hypertension and proteinuria after 20 weeks. Current concepts suggest that the pathophysiology of preeclampsia and intrauterine growth retardation results from an imbalance of angiogenic factors.

A new angiogenic factor EG-VEGF (Endocrine Gland- Derived Vascular Endothelial Growth Factor) also known as Prokineticin 1 (PROK1) appears to be emerging in the pathophysiology of PE. EG-VEGF is a circulating factor which belongs to the family of prokinetics. Dr Alfaidy's MAB2 team at the Cancer and Infections Biology Laboratory (U1292 Biosanté INSERM / UGA / CEA, CEA Grenoble) demonstrated its key role in the control of key processes in placental development and provided evidence through the development of an animal model of preeclampsia. EG -VEGF is directly involved in the development of Pre-Eclampsia. Few studies have evaluated the expression of EG-VEGF in the human placenta.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-15
• Study Start: 2022-06-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

• All patients who have given birth by cesarean section at the maternity University Hospital Saint Etienne and all underwent a placenta pathological examination at the Saint Etienne University Hospital.
• For the pre-eclampsia group: patient with a diagnosis of pre-eclampsia
• For the control group: patient who had a normal pregnancy

Exclusion Criteria

• Patient who gave birth naturally
• Underage patients or under guardianship
• Patients who do not speak or read French
• Childbirth under X

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
preeclampsia group	Placenta pathological examination	25 patients with a diagnostic of preeclampsia, having undergone a placental pathological examination and having given birth by cesarean section. A cross-referencing of data with programme for medicalization of information systems (PMSI) will be realized. Placenta pathological examination will be performed.
control group	Placenta pathological examination	10 patients who had a normal pregnancy, having undergone a placental pathological examination and having given birth by cesarean section. A cross-referencing of data with PMSI will be realized. Placenta pathological examination will be performed.

Primary Outcome Measures

Name	Time	Method
Immuno-localization of EG-VEGF staining (ImageJ®) by immunohistochemistry	At delivery	Measured by placenta pathological examination (immunohistochemistry technical).
Quantification of EG-VEGF staining (ImageJ®) by immunohistochemistry	At delivery	Measured by placenta pathological examination (immunohistochemistry technical).

Secondary Outcome Measures

Name	Time	Method
Quantification of the staining of PROKR1 (ImageJ®) by immunohistochemistry	At delivery	Measured by placenta pathological examination (immunohistochemistry technical).
Quantification of the staining of PROKR2 (ImageJ®) by immunohistochemistry Measure by placenta pathological examination (immunohistochemistry technical).	At delivery	Measured by placenta pathological examination (immunohistochemistry technical).
Presence of an anticoagulant treatment	At delivery	treatment by aspirin or Heparin or low molecular weight heparins (LMWH)
Presence of at least one chronic maternal pathologies describe below	At delivery	diabetes, hypertension, kidney disease, Systemic Lupus Erythematosus (SLE), antiphospholipid syndrome
Obstetric history	At delivery	Pre-Eclampsia (PE) and intra uterine growth retardation (IUGR), term of onset and severity of Pre-Eclampsia (PE)
Immuno-localization of the staining of PROKR2 (ImageJ®) by immunohistochemistry	At delivery	Measured by placenta pathological examination (immunohistochemistry technical).
Immuno-localization of the staining of PROKR1 (ImageJ®) by immunohistochemistry	At delivery	Measured by placenta pathological examination (immunohistochemistry technical).

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France