Study of the Physiology of Pre-eclampsia and Vascular IUG... | NCT03626233

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

NCT03626233

Sponsor

Centre Hospitalier Intercommunal Creteil

Status

Recruiting

Last Update Posted

Jun 12, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Pre-Eclampsia

Interventions

collect of placenta, blood and urinary samples at delivery

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 6, 2018Actual

Primary Completion Date

Aug 2028Estimated

Completion Date

Aug 2028Estimated

First Submitted Date

Aug 8, 2018

First Submission Date that Met QC Criteria

Aug 8, 2018

First Posted Date

Aug 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2026

Last Update Posted Date

Jun 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vascular group		Pregnant women with vascular pathology	Other: 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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
collect of placenta, blood and urinary samples at delivery	Other	collect of placenta, blood and urinary samples at delivery	Control group Vascular group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
genomic analysis on blood	by ChIP-seq	day of delivery
genomic analysis on placenta	by immunohistochemistry an polymerase chain-reaction

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

pregnant women with or without vascular pathology

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Diane REDEL	Contact	145175530	0033	diane.redel@chicreteil.fr
camille Jung	Contact	157022268	0033	camille.jung@chicreteil.fr

Overall Officials

Name	Affiliation	Role
Edouard Lecarpentier, MD PhD	CHI CRETEIL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHi Creteil	Recruiting	Créteil		94000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided