NCT00485784

Brief Summary

This is a prospective multicentric study including four clinical units of Gynecology and Obstetrics (3 public health hospitals and one private team), one research team in Hematology and one Center of Clinical investigation (CIC). The objective is to identify, beside the pregnancy, in a population of patients with a preeclampsia (PE), with fetus presenting with growth restriction (IUGR) and a fetal demise (FD) a modification of circulating endothelial biomarkers compared with normal pregnancy. We want to understand better the physiopathology of preeclampsia and propose to patients with an endothelial dysfunction a early prevention of preeclampsia. Patients will be tested 3 times : At the pregnancy events; then 8 weeks and 12 months after the birth. Four groups will be constituted among patients: PE, IUGR, FD and normal pregnancy. Normal pregnancy will be tested as controls. The next pregnancy presenting in the unit to medical pregnancy follow up will be invited to participate. The main judgment criteria will be the levels of endothelial microparticles 8 weeks after the event. The study will last 3 years. The number of patient to include is 280.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

First Submitted

Initial submission to the registry

June 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2007

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

5 years

First QC Date

June 12, 2007

Last Update Submit

August 27, 2014

Conditions

Pre-Eclampsia

Keywords

Identify in a population of patients with a PE, an IUGR and a FD a modification of circulating endothelial biomarkers compared with normal pregnancy.

Outcome Measures

Primary Outcomes (1)

  • Bring to light except the pregnancy within a population of presenting patients one EP, a RCIU and a MFIU a modification of biomarkers circulating endothéliaux with regard to the normal pregnancy.

    3 years

Study Arms (4)

control group

SHAM COMPARATOR

control group

Other: Blood test

prééclampsies group

EXPERIMENTAL

prééclampsies group

Other: Blood test

RCIU group

EXPERIMENTAL

RCIU group

Other: Blood test

MFIU group

EXPERIMENTAL

MFIU group

Other: Blood test

Interventions

Blood testOTHER

Blood test

MFIU groupRCIU groupcontrol groupprééclampsies group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant patients aged more than 18 years and more than 12 weeks of gestation for FD group, 20 weeks of gestation for PE or IUGR group , presenting either:
  • PE (arterial pressure more than 140 mm Hg and 90 mm Hg) and at least a proteinuria evaluated on stick (one point) or 300 mg/24h.
  • IUGR with biometries below 5° percentile according to the graphs of fetal echography college after 20 weeks of gestation.
  • FD after 12 weeks of gestation or with a cranio-caudal length of more than 45 mm.
  • social security cover
  • written informed consent

You may not qualify if:

  • Foetal malformation
  • APLS known
  • Set back of patient consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital Saint-Joseph - Service de Gynécologie-Obstétrique

Marseille, 13008, France

Location

Hôpital Nord

Marseille, 13015, France

Location

Hôpital de la Conception

Marseille, 13385, France

Location

Chu Nice Hopital de L'Archet

Nice, France

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Florence BRETELLE, PU-PH

    Unité Mère-Enfant Hôpital Nord 13005 Marseille - Assistance Publique Hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2007

First Posted

June 13, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2012

Last Updated

August 28, 2014

Record last verified: 2014-08

Locations

FR(4)