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

NCT01490489 | Completed

• 2 other identifiers: C09-432009-A01304-53
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre-eclampsia; Intra-uterine Growth Retardation

Keywords

EG-VEGF; Endocrine Gland-derived Vascular Endothelial Growth Factor; Pre-eclampsia; intra-uterine growth retardation; prognosis

Outcome Measures

Primary Outcomes (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

  Between 14 and 18 weeks of gestation

Secondary Outcomes (4)

• Correlation between the level of uterine artery transformation and the level of EG-VEGF.

  Between 14 and 18 week of gestation

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

  Between 14 and 18 week of gestation

• Measure the circulating levels of the new angiogenic factor EG-VEGF

  Between 14 and 18 weeks of gestation

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

  Between 14 and 18 weeks of gestation

Study Arms (1)

Pregnent women with blood sample

OTHER

Other: blood sample and doppler Ultrasound of uterine arteries

Interventions

blood sample and doppler Ultrasound of uterine arteries OTHER

* 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

Pregnent women with blood sample

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Clinical investigation center of the Grenoble University Hospital

Grenoble, Isere, 38043, France

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pascale Hoffmann, MD/PHD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

• Nadia ALFAIDI, PHD

  inserm U878

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 13, 2011
• Study Start: July 11, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 13, 2015
• Last Updated: November 18, 2025

Record last verified: 2021-08

Locations

FR (1)