Placental Expression of EG-VEGF and Its PROKR1 and PROKR2 Receptors in Preeclampsia Patients. (PRE-EVE)

June 30, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
preeclampsia group

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immuno-localization of EG-VEGF staining (ImageJ®) by immunohistochemistry
Time Frame: At delivery
Measured by placenta pathological examination (immunohistochemistry technical).
At delivery
Quantification of EG-VEGF staining (ImageJ®) by immunohistochemistry
Time Frame: At delivery
Measured by placenta pathological examination (immunohistochemistry technical).
At delivery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Commissariat A L'energie Atomique

Investigators

  • Principal Investigator: Tiphaine BARJAT, MD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN622021/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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