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Micro Array Analysis in Preeclampsia

This study is currently recruiting participants.
Verified July 2016 by Assistance Publique Hopitaux De Marseille
Sponsor:
ClinicalTrials.gov Identifier:
NCT01914809
First Posted: August 2, 2013
Last Update Posted: July 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
  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: None (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 ]
    blood samples


Secondary Outcome Measures:
  • analysis of placental transcriptional profile. [ Time Frame: 36 months ]
    biopsie placentaire


Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: January 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01914809     History of Changes
Other Study ID Numbers: 2010-A00633-36
2010-04 ( Other Identifier: AP HM )
First Submitted: July 11, 2013
First Posted: August 2, 2013
Last Update Posted: July 7, 2016
Last Verified: July 2016

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