Back to resultsMicro Array Analysis in Preeclampsia
Primary Purpose
Preeclampsia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
samples blood
biopsy placentaire
Sponsored by
About this trial
This is an interventional other trial for Preeclampsia
Eligibility 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).
Sites / Locations
- Assistance Publique Hopitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
group with a preeclampsia before 34 SA
group with a normal pregnancy
Arm Description
Outcomes
Primary Outcome Measures
predictive markers of preeclampsia
blood samples
Secondary Outcome Measures
analysis of placental transcriptional profile.
biopsie placentaire
Full Information
NCT ID
NCT01914809
First Posted
July 11, 2013
Last Updated
September 24, 2020
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01914809
Brief Title
Micro Array Analysis in Preeclampsia
Official Title
Micro Array Analysis in Preeclampsia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2011 (Actual)
Primary Completion Date
January 25, 2021 (Anticipated)
Study Completion Date
January 25, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group with a preeclampsia before 34 SA
Arm Type
Experimental
Arm Title
group with a normal pregnancy
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
samples blood
Intervention Type
Other
Intervention Name(s)
biopsy placentaire
Primary Outcome Measure Information:
Title
predictive markers of preeclampsia
Description
blood samples
Time Frame
36 months
Secondary Outcome Measure Information:
Title
analysis of placental transcriptional profile.
Description
biopsie placentaire
Time Frame
36 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
florence bretelle
Email
florence.bretelle@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LOIC MONDOLONI
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
florence bretelle
Email
florence.bretelle@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
florence bretelle
12. IPD Sharing Statement
Learn more about this trial
Micro Array Analysis in Preeclampsia
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