Micro Array Analysis in Preeclampsia

This study is currently recruiting participants.
Verified July 2013 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01914809
First received: July 11, 2013
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

Preeclampsia is a frequent pathology. His etiology is doubtful.

Targets :

The study target is to identify a risk of preeclampsia group obtained with transcriptom analysis from circulating peripheric cells.

Design:

Multidisciplinary study (Gynaecology-Obstetric, Immunology, North CIC).

The study of the transcriptional history of peripheral blood cells of 2patients groups:

  • A patient group with a preeclampsia before 34 SA
  • A patient group with a normal pregnancy paired on main confusion factors. Blood sampling will be collected at the diagnosis and 8 weeks after delivery.

Results and perspectives

  • Obtain a transcriptionnal signature of preeclampsia
  • To identify new mechanism of the disease
  • Identification of a specific transcriptom analysis with the comparison after delivery For long-term, the target is to identify risk patient in order to conduct easily preventive clinical trials in preeclamsia (primary prevention) and to consider a specific follow-up for risk patients.

Condition Intervention
Preeclampsia
Other: samples blood
Other: biopsy placentaire

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Micro Array Analysis in Preeclampsia

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • predictive markers of preeclampsia [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    blood samples


Secondary Outcome Measures:
  • analysis of placental transcriptional profile. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    biopsie placentaire


Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group with a preeclampsia before 34 SA Other: samples blood Other: biopsy placentaire
group with a normal pregnancy Other: samples blood Other: biopsy placentaire

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A prééclampsie (blood pressure superior to 140 mmHg and to 90 mmHg) and at least a cross of protein in the strip and/or more of 300mg / 24h after 20 LIMITED COMPANIES and before 34 limited companies.
  • An informed consent signed by the patient will necessarily have to be obtained.
  • Woman having been taken care during the pregnancy or at the time of the childbirth(delivery) by one of the participating teams to the current project.
  • Caucasian Patient
  • Wait primigeste and nullipare

Exclusion Criteria:

  • Major Patient protected by the law.
  • Patient deprived of freedom for administrative or judicial reasons.
  • Patient not benefiting from a national insurance scheme.
  • Refusal of the patient to participate in the study.
  • Not Caucasian Patient
  • Multipare Wait
  • Multiple Pregnancy
  • Existence of foetal deformation explaining a delay of growth or a foetal death in utero.
  • Age 18 years and > 40 years.
  • Absence of written consent or impossibility to receive the written consent (language or understanding).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01914809

Contacts
Contact: florence bretelle florence.bretelle@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: florence bretelle       florence.bretelle@ap-hm.fr   
Principal Investigator: florence bretelle         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: LOIC MONDOLONI Assistance Publique Hopitaux De Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01914809     History of Changes
Other Study ID Numbers: 2010-A00633-36, 2010-04
Study First Received: July 11, 2013
Last Updated: July 31, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on April 17, 2014