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

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

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

Study Overview

• Status: Recruiting
• Conditions: Pre-Eclampsia
• Intervention / Treatment: Other: collect of placenta, blood and urinary samples at delivery

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Diane REDEL; Phone Number: 0033 145175530; Email: diane.redel@chicreteil.fr
• Study Contact Backup: Name: camille Jung; Phone Number: 0033 157022268; Email: camille.jung@chicreteil.fr

Study Locations

• France
  • Creteil, France, 94000
    • Recruiting
    • CHI Créteil
    • Contact: Diane REDEL; Phone Number: 0033 145175530; Email: diane.redel@chicreteil.fr
    • Principal Investigator: Edouard LECARPENTIER, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

pregnant women with or without vascular pathology

Description

Inclusion Criteria:

• pregnant women
• With or without vascular pathology

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vascular group; Pregnant women with vascular pathology	Other: collect of placenta, blood and urinary samples at delivery; collect of placenta, blood and urinary samples at delivery
Control group; Pregnancy without any vascular complication; Delivery before or after 37 weeks of gestation (GW); In case of delivery after 37GW: birth by cesarean delivery	Other: collect of placenta, blood and urinary samples at delivery; collect of placenta, blood and urinary samples at delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
genomic analysis on placenta	by chromatin immunoprecipitation-sequencing (ChIP-seq)	day of delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
genomic analysis on blood	by ChIP-seq	day of delivery
genomic analysis on placenta	by immunohistochemistry an polymerase chain-reaction	day of delivery
VEGF blood level		day of delivery
PLGF blood level		day of delivery
sFlt1 blood level		day of delivery
sKDR blood level		day of delivery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Investigators: Principal Investigator: Edouard Lecarpentier, MD PhD, CHI Créteil

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2018
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: CPVP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No