Micro Array Analysis in Preeclampsia

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014