PreeclampsiaPRE-EVENCT04846686
Placental Expression of EG-VEGF and Its PROKR1 and PROKR2 Receptors in Preeclampsia Patients.
An observational study of Preeclampsia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Placenta pathological examination
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patient who gave birth naturally
- Underage patients or under guardianship
- Patients who do not speak or read French
- Childbirth under X
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Preeclampsia
- Being tested
- Placenta pathological examination
- Keywords
- Preeclampsia, EG-VEGF, Prokineticin, cesarean, placenta pathological examination, pregnancy, PROK1 receptor, PROKR2 receptor
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placenta pathological examinationBiological
a placenta pathological examination will be analyzed to examine quantification of EG-VEGF, PROKR1 and PROKR2 receptors.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Placenta pathological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immuno-localization of EG-VEGF staining (ImageJ®) by immunohistochemistry
Measured by placenta pathological examination (immunohistochemistry technical).
Measured: At delivery
Quantification of EG-VEGF staining (ImageJ®) by immunohistochemistry
Measured by placenta pathological examination (immunohistochemistry technical).
Measured: At delivery
Secondary outcomes (7)
Immuno-localization of the staining of PROKR1 (ImageJ®) by immunohistochemistry
Measured by placenta pathological examination (immunohistochemistry technical).
Measured: At delivery
Quantification of the staining of PROKR1 (ImageJ®) by immunohistochemistry
Measured by placenta pathological examination (immunohistochemistry technical).
Measured: At delivery
Immuno-localization of the staining of PROKR2 (ImageJ®) by immunohistochemistry
Measured by placenta pathological examination (immunohistochemistry technical).
Measured: At delivery
Quantification of the staining of PROKR2 (ImageJ®) by immunohistochemistry Measure by placenta pathological examination (immunohistochemistry technical).
Measured by placenta pathological examination (immunohistochemistry technical).
Measured: At delivery
Presence of at least one chronic maternal pathologies describe below
diabetes, hypertension, kidney disease, Systemic Lupus Erythematosus (SLE), antiphospholipid syndrome
Measured: At delivery
Obstetric history
Pre-Eclampsia (PE) and intra uterine growth retardation (IUGR), term of onset and severity of Pre-Eclampsia (PE)
Measured: At delivery
Presence of an anticoagulant treatment
treatment by aspirin or Heparin or low molecular weight heparins (LMWH)
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Jun 2022
- Primary completion31 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Responsible party
- Sponsor
- Investigators
- Tiphaine BARJAT, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846686
- Sponsor's protocol ID
- IRBN622021/CHUSTE
- Acronym
- PRE-EVE
- Status last verified
- Jun 2023
- First submitted
- 13 Apr 2021
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Expression of EG-VEGF and Its PROKR1 and PROKR2 Receptors in Preeclampsia Patients.
- ClinicalTrials.gov ID
- NCT04846686
- Acronym / sponsor ID
- PRE-EVE / IRBN622021/CHUSTE
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, EG-VEGF, Prokineticin, cesarean, placenta pathological examination, pregnancy, PROK1 receptor, PROKR2 receptor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preeclampsia group | – | Biological: Placenta pathological examination25 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 | – | Biological: Placenta pathological examination10 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patient who gave birth naturally
- Underage patients or under guardianship
- Patients who do not speak or read French
- Childbirth under X
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placenta pathological examinationa placenta pathological examination will be analyzed to examine quantification of EG-VEGF, PROKR1 and PROKR2 receptors. | Biological | control group, preeclampsia group |
Primary outcome
Immuno-localization of EG-VEGF staining (ImageJ®) by immunohistochemistry
Time frame: At delivery
Measured by placenta pathological examination (immunohistochemistry technical).
Quantification of EG-VEGF staining (ImageJ®) by immunohistochemistry
Time frame: At delivery
Measured by placenta pathological examination (immunohistochemistry technical).
7 secondary outcomes
Immuno-localization of the staining of PROKR1 (ImageJ®) by immunohistochemistry
Time frame: At delivery
Quantification of the staining of PROKR1 (ImageJ®) by immunohistochemistry
Time frame: At delivery
Immuno-localization of the staining of PROKR2 (ImageJ®) by immunohistochemistry
Time frame: At delivery
Quantification of the staining of PROKR2 (ImageJ®) by immunohistochemistry Measure by placenta pathological examination (immunohistochemistry technical).
Time frame: At delivery
Presence of at least one chronic maternal pathologies describe below
Time frame: At delivery
Obstetric history
Time frame: At delivery
Presence of an anticoagulant treatment
Time frame: At delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiphaine BARJAT, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immuno-localization of EG-VEGF staining (ImageJ®) by immunohistochemistry (time frame: At delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.