Micro Array Analysis in Preeclampsia

September 24, 2020 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Recruiting
        • Assistance Publique Hopitaux de Marseille
        • Contact:
        • Principal Investigator:
          • Florence BRETELLE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group with a preeclampsia before 34 SA
Other: samples blood
Other: biopsy placentaire
Other: group with a normal pregnancy
Other: samples blood
Other: biopsy placentaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
predictive markers of preeclampsia
Time Frame: 36 months
blood samples
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analysis of placental transcriptional profile.
Time Frame: 36 months
biopsie placentaire
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2011

Primary Completion (Anticipated)

January 25, 2021

Study Completion (Anticipated)

January 25, 2021

Study Registration Dates

First Submitted

July 11, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 24, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-A00633-36
  • 2010-04 (AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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