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Pre-eclampsiaEGEVENCT01490489

EG-VEGF : Potential Marker of Pre-eclampsia and / or Intrauterine Growth Restriction

A study testing blood sample and doppler Ultrasound of uterine arteries in people with Pre-eclampsia and Intra-uterine Growth Retardation, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the potential prognostic value of seric concentrations of EG-VEGF for Pre-eclampsia and/or intrauterine growth restriction and will allow checking whether plasma levels of EG-VEGF at 14-18 weeks of gestation could be proposed as prognostic marker for preeclampsia. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
blood sample and doppler Ultrasound of uterine arteries
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
1 siteFrance
Study dates
11 Jul 2011to 13 Mar 2015
Phase
Interventional
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women older than 17 years old
  • All pregnant patients enrolled before 14 SG and with singleton, irrespectively of their parity
  • Pregnant woman living in the Grenoble area
  • Women accepting, the participation to the study.

Who cannot join

  • Inability to understand the project
  • Persons deprived of their liberty by judicial or administrative decisions
  • Person under legal protection

Trial locations and contacts

1 site in 1 country.

France1 site
  • Clinical investigation center of the Grenoble University Hospital

    Grenoble, Isere, 38043

Other trials in France

About this study

Official title: EG-VEGF (Endocrine Gland-derived Vascular Endothelial Growth Factor) in Normal and Pathological Pregnancies: Potential Marker of Pre-eclampsia and / or Intrauterine Growth Restriction

The purpose of this study is to assess the potential prognostic value of seric concentrations of EG-VEGF for Pre-eclampsia and/or intrauterine growth restriction and will allow checking whether plasma levels of EG-VEGF at 14-18 weeks of gestation could be proposed as prognostic marker for preeclampsia.

Read the detailed description

Successful human placentation depends on adequate transformation of the uteroplacental vasculature by extravillous trophoblast (EVT) following proliferation, migration, and invasion of these cells into the maternal decidua. This process of vascular remodelling rises to a peak by the end of the first trimester and declines rapidly thereafter. Poor invasion can lead to the development of pathological condition such as Pre-eclampsia (PE) and intrauterine growth restriction (IUGR). PE affects 5-6 % of pregnancies in France and causes the death of ten or so women per year. Our research project is dedicated to the comprehension of the mechanisms underlying the development of PE and to the search of gold prognostic marker of this pathology. We were particularly interested in the study of the new angiogenic factor, EG-VEGF, recently reported as new factor specific to endocrine glands including the placenta. In recent results obtained by our team, we have shown that i) placental EG-VEGF showed a peak of expression just before the establishment of the foeto-maternal circulation ii) EG-VEGF receptors, PKR1 and PKR2 were also expressed during the first trimester of pregnancy and iii) EG-VEGF expression and that of its receptor PKR1 were up-regulated by hypoxia. In our last publication "under press in JCMM" we have shown that EG-VEGF inhibits EVT migration and invasion. More importantly, we have succeeded to measure EG-VEGF circulating levels in non pregnant and in pregnant women at the three trimesters of pregnancy and showed that its highest levels (5 times the non pregnant levels) were found during the first trimester of pregnancy with a significant decrease thereafter. Furthermore, on a cohort of 19 PE patient and 21 age matched controls, we have observed a significant increase in EG-VEGF levels in the PE group. Therefore we hypothesize that EG-VEGF could play an important role in human placentation and that a persistence in its expression over the first trimester of pregnancy may contribute to the development of PE.

Based on the Doppler analysis method for the assessment of uterine artery transformation by the end of 1st trimester, we propose to search for a correlation between the circulating levels of the new angiogenic factor EG-VEGF in the sera of pregnant woman between 14 to 18 WG, and the development of PE and/or IUGR. Doppler ultrasonography is a predictive method of the pregnancy outcome at the time of the development of the disease (1st to 2nd trimester), before threatening symptoms launch (end of the 2nd to the 3rd trimester). In normal pregnancy, impedance to flow in the uterine arteries decreases with gestation as result of trophoblastic invasion of the spiral arteries and their conversion into low-resistance vessels by the end of first trimester of pregnancy. Therefore, the present study will also allow the search for a negative correlation between the level of uterine artery transformation and the level of EG-VEGF. The study will be conducted in collaboration with the Clinical centre of the Grenoble CHU Hospital (Dr JL. Cracowski). In this study we plan to include 500 pregnant pregnant women. Patients will be recruited at the time of their first ultrasonography between 11 and 13 WG and included in the study between 14 and 18 WG. For each patient a blood sample will be taken for the measurement of circulating EG-VEGF and Doppler analysis for uterine artery transformation will be performed. These results will provide information concerning the potential prognostic value of seric concentrations of EG-VEGF for PE and/or IUGR and will allow checking whether plasma levels of EG-VEGF at 14-18 weeks of gestation could be proposed as prognostic marker for preeclampsia.

Being tested
blood sample and doppler Ultrasound of uterine arteries
Keywords
EG-VEGF, Endocrine Gland-derived Vascular Endothelial Growth Factor, Pre-eclampsia, intra-uterine growth retardation, prognosis
Medical subject headings
Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood sample and doppler Ultrasound of uterine arteriesOther

    • 36 ml of blood samples (serum and plasma) will be collected
    • After a bed rest supine for 15 minutes, ultrasound Doppler from each of the uterine arteries will be performed to search for Notch
Study groups in NCT01490489
Study groupRoleWhat they receive
Pregnent women with blood sampleOtherNot described
Receives: Other: blood sample and doppler Ultrasound of uterine arteries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure of the circulating levels of EG-VEGF in the sera of pregnant woman between 14 and 18 WG

    Measure the circulating levels of the new angiogenic factor EG-VEGF in the sera of pregnant woman between 14 and 18 WG to determine whether EG-VEGF could represent a prognostic marker for the development of PE and/or IUGR

    Measured: Between 14 and 18 weeks of gestation

Secondary outcomes (4)
  1. Correlation between the level of uterine artery transformation and the level of EG-VEGF.

    Correlation between the level of EG-VEGF and the level of uterine artery transformation evaluated by Doppler ultrasound.

    Measured: Between 14 and 18 week of gestation

  2. Measure the circulating levels of other pro and/or anti-angiogenic factors

    Measure the circulating levels of other pro and/or anti-angiogenic factors that could represent alternative biomarkers in the development of placental pathologies of vascular origin. As candidates, we will measure the soluble receptor of VEGF (s-flt) and Bone morphogenetic protein-9 (BMP9)

    Measured: Between 14 and 18 week of gestation

  3. Measure the circulating levels of the new angiogenic factor EG-VEGF

    Measure the circulating levels of the new angiogenic factor EG-VEGF in the sera of pregnant woman between 14 and 18 WG to determine whether EG-VEGF could represent a prognostic marker for the development of PE.

    Measured: Between 14 and 18 weeks of gestation

  4. Measure the circulating levels of the new angiogenic factor EG-VEGF in the sera

    Measure the circulating levels of the new angiogenic factor EG-VEGF in the sera of pregnant woman between 14 and 18 WG to determine whether EG-VEGF could represent a prognostic marker for the development of IUGR

    Measured: Between 14 and 18 weeks of gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2011 (estimated)
  2. Study start11 Jul 2011
  3. Primary completionMar 2015
  4. Study completion13 Mar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01490489
Sponsor's protocol ID
C09-43
Other IDs
2009-A01304-53
Acronym
EGEVE
Status last verified
Aug 2021
First submitted
8 Dec 2011
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing blood sample and doppler Ultrasound of uterine arteries in people with Pre-eclampsia and Intra-uterine Growth Retardation, run by Institut National de la Santé Et de la Recherche Médicale, France 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 4 inclusion and 3 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 18 Nov 2025. 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?

Measure of the circulating levels of EG-VEGF in the sera of pregnant woman between 14 and 18 WG (time frame: Between 14 and 18 weeks of gestation). 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 18 Nov 2025.

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