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

Pre-Eclampsia Clinical Trial

— CPVP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03626233
• Other study ID #: CPVP
• Status: Recruiting
• Start date: August 6, 2018
• Est. completion date: April 2024

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Diane REDEL
• Phone: 145175530
• Email: diane.redel[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pregnant women

• With or without vascular pathology

Exclusion Criteria:

• refusal to participate

• multiple pregnancy

• major fetal malformation diagnosed during pregnancy follow-up

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

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

Locations

Country	Name	City	State
France	CHi Creteil	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	genomic analysis on placenta	by chromatin immunoprecipitation-sequencing (ChIP-seq)	day of delivery
Secondary	genomic analysis on blood	by ChIP-seq	day of delivery
Secondary	genomic analysis on placenta	by immunohistochemistry an polymerase chain-reaction	day of delivery
Secondary	VEGF blood level		day of delivery
Secondary	PLGF blood level		day of delivery
Secondary	sFlt1 blood level		day of delivery
Secondary	sKDR blood level		day of delivery