NCT03626233

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Aug 2018Aug 2028

Study Start

First participant enrolled

August 6, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

10 years

First QC Date

August 8, 2018

Last Update Submit

June 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • genomic analysis on placenta

    by chromatin immunoprecipitation-sequencing (ChIP-seq)

    day of delivery

Secondary Outcomes (6)

  • genomic analysis on blood

    day of delivery

  • genomic analysis on placenta

    day of delivery

  • VEGF blood level

    day of delivery

  • PLGF blood level

    day of delivery

  • sFlt1 blood level

    day of delivery

  • +1 more secondary outcomes

Study Arms (2)

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

collect of placenta, blood and urinary samples at delivery

Control groupVascular group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pregnant women with or without vascular pathology

You may qualify if:

  • pregnant women
  • With or without vascular pathology

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHi Creteil

Créteil, 94000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for maternal DNA sequencing and angiogenic factors (VEGF, PLGF, sFLt-1, sQDR) Urinary samples: Angiogenic factors Placenta: for placenta DNA sequencing and angiogenic factors

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Edouard Lecarpentier, MD PhD

    CHI CRETEIL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2018

First Posted

August 10, 2018

Study Start

August 6, 2018

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations