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Completed

NCT Number: NCT04846686

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

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Chu Saint-Etienne

Saint-Etienne, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placenta pathological examination

Biological

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

Primary outcomes

  1. Immuno-localization of EG-VEGF staining (ImageJ®) by immunohistochemistry

    Time frame: At delivery

    Measured by placenta pathological examination (immunohistochemistry technical).

  2. Quantification of EG-VEGF staining (ImageJ®) by immunohistochemistry

    Time frame: At delivery

    Measured by placenta pathological examination (immunohistochemistry technical).

Secondary outcomes

  1. Immuno-localization of the staining of PROKR1 (ImageJ®) by immunohistochemistry

    Time frame: At delivery

    Measured by placenta pathological examination (immunohistochemistry technical).

  2. Quantification of the staining of PROKR1 (ImageJ®) by immunohistochemistry

    Time frame: At delivery

    Measured by placenta pathological examination (immunohistochemistry technical).

  3. Immuno-localization of the staining of PROKR2 (ImageJ®) by immunohistochemistry

    Time frame: At delivery

    Measured by placenta pathological examination (immunohistochemistry technical).

  4. 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).

  5. Presence of at least one chronic maternal pathologies describe below

    Time frame: At delivery

    diabetes, hypertension, kidney disease, Systemic Lupus Erythematosus (SLE), antiphospholipid syndrome

  6. Obstetric history

    Time frame: At delivery

    Pre-Eclampsia (PE) and intra uterine growth retardation (IUGR), term of onset and severity of Pre-Eclampsia (PE)

  7. Presence of an anticoagulant treatment

    Time frame: At delivery

    treatment by aspirin or Heparin or low molecular weight heparins (LMWH)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Commissariat A L'energie Atomique

Registry information

Acronym: PRE-EVE

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 15, 2021
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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