search
Back to results

Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications

Primary Purpose

Pre-Eclampsia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood test
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-Eclampsia focused on measuring Identify in a population of patients with a PE, an IUGR and a FD a modification of circulating endothelial biomarkers compared with normal pregnancy.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.
  • Normal pregnancy adjusted for gestational age and parity : Patient should have no cardio-vascular past with a normal complication at the inclusion time and from which pregnancy remains uneventful until the term. The onset of premature delivery, hypertension or fetal growth restriction will exclude patients from the control group.
  • social security cover
  • written informed consent

Exclusion Criteria:

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

Sites / Locations

  • Hôpital Saint-Joseph - Service de Gynécologie-Obstétrique
  • Hôpital Nord
  • Hôpital de la Conception
  • Chu Nice Hopital de L'Archet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Experimental

Experimental

Arm Label

control group

prééclampsies group

RCIU group

MFIU group

Arm Description

control group

prééclampsies group

RCIU group

MFIU group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 12, 2007
Last Updated
August 27, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
search

1. Study Identification

Unique Protocol Identification Number
NCT00485784
Brief Title
Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications
Official Title
Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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.

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Sham Comparator
Arm Description
control group
Arm Title
prééclampsies group
Arm Type
Experimental
Arm Description
prééclampsies group
Arm Title
RCIU group
Arm Type
Experimental
Arm Description
RCIU group
Arm Title
MFIU group
Arm Type
Experimental
Arm Description
MFIU group
Intervention Type
Other
Intervention Name(s)
Blood test
Intervention Description
Blood test
Primary Outcome Measure Information:
Title
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.
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Normal pregnancy adjusted for gestational age and parity : Patient should have no cardio-vascular past with a normal complication at the inclusion time and from which pregnancy remains uneventful until the term. The onset of premature delivery, hypertension or fetal growth restriction will exclude patients from the control group. social security cover written informed consent Exclusion Criteria: Foetal malformation APLS known Set back of patient consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence BRETELLE, PU-PH
Organizational Affiliation
Unité Mère-Enfant Hôpital Nord 13005 Marseille - Assistance Publique Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Saint-Joseph - Service de Gynécologie-Obstétrique
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Hôpital Nord
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Hôpital de la Conception
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Chu Nice Hopital de L'Archet
City
Nice
Country
France

12. IPD Sharing Statement

Learn more about this trial

Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications

We'll reach out to this number within 24 hrs