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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04846686
Other study ID # IRBN622021/CHUSTE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date January 1, 2023

Study information

Verified date June 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date January 1, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Biological:
Placenta pathological examination
a placenta pathological examination will be analyzed to examine quantification of EG-VEGF, PROKR1 and PROKR2 receptors.

Locations

Country Name City State
France Chu Saint-Etienne Saint-Étienne

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne Commissariat A L'energie Atomique

Country where clinical trial is conducted

France, 

Outcome

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