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Recruiting NCT03626233

Study of the Physiology of Pre-eclampsia and Vascular IUGR With Constitution of a Biological Collection

— Observational Pre-Eclampsia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: collect of placenta, blood and urinary samples at delivery.
Who it may be relevant to
Registry conditions: Pre-Eclampsia. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study of the Physiology of Pre-eclampsia and Vascular Intrauterine Growth Restriction With Constitution of a Biological Collection

Overview

Preeclampsia and intrauterine growth retardation (IUGR) are serious and frequent pathologies, specific to pregnancy. They represent 70 000 new cases a year, or 9% of pregnancies and cause 50,000 premature births per year in France. The consequences in terms of morbidity and perinatal morbidity and the medical and economic costs make it an issue public health. Pre-eclampsia associates maternal hypertension with dysfunction kidney. There is no cure for pre-eclampsia or IUGR vascular during pregnancy. These pathologies invariably evolve towards a maternal and / or fetal aggravation sometimes very fast. Primary prevention and secondary education and screening for these pathologies are still insufficient. A better understanding of the pathophysiology of these placental vascular pathologies is necessary for the development of supported medical, obstetric and pediatric that will improve the state of health maternal and neonatal

Interventions

  • Other collect of placenta, blood and urinary samples at delivery
    collect of placenta, blood and urinary samples at delivery

Primary outcome measures

  • genomic analysis on placenta [Time frame: day of delivery]
Secondary outcome measures (6)
  • genomic analysis on blood [Time frame: day of delivery]
  • genomic analysis on placenta [Time frame: day of delivery]
  • VEGF blood level [Time frame: day of delivery]
  • PLGF blood level [Time frame: day of delivery]
  • sFlt1 blood level [Time frame: day of delivery]
  • sKDR blood level [Time frame: day of delivery]

Eligibility criteria

Inclusion criteria

  • pregnant women
  • With or without vascular pathology

Exclusion criteria

  • refusal to participate
  • multiple pregnancy
  • major fetal malformation diagnosed during pregnancy follow-up

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHi Creteil — Créteil

Identifiers

NCT: NCT03626233 · CPVP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗