NCT04846686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

7 months

First QC Date

April 13, 2021

Last Update Submit

June 30, 2023

Conditions

Keywords

PreeclampsiaEG-VEGFProkineticincesareanplacenta pathological examinationpregnancyPROK1 receptorPROKR2 receptor

Outcome Measures

Primary Outcomes (2)

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

    Measured by placenta pathological examination (immunohistochemistry technical).

    At delivery

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

    Measured by placenta pathological examination (immunohistochemistry technical).

    At delivery

Secondary Outcomes (7)

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

    At delivery

  • Quantification of the staining of PROKR1 (ImageJ®) by immunohistochemistry

    At delivery

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

    At delivery

  • Quantification of the staining of PROKR2 (ImageJ®) by immunohistochemistry Measure by placenta pathological examination (immunohistochemistry technical).

    At delivery

  • Presence of at least one chronic maternal pathologies describe below

    At delivery

  • +2 more secondary outcomes

Study Arms (2)

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

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

Interventions

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

control grouppreeclampsia group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

placental

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Tiphaine BARJAT, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 15, 2021

Study Start

June 1, 2022

Primary Completion

December 31, 2022

Study Completion

January 1, 2023

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations