Micro Array Analysis in Preeclampsia

NCT ID: NCT01914809

Last Updated: 2020-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-15
• Study Completion Date: 2021-01-25

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.

Conditions

Preeclampsia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

group with a preeclampsia before 34 SA

Group Type: EXPERIMENTAL

samples blood

Intervention Type: OTHER

biopsy placentaire

Intervention Type: OTHER

group with a normal pregnancy

Group Type: OTHER

samples blood

Intervention Type: OTHER

biopsy placentaire

Intervention Type: OTHER

Interventions

samples blood

Intervention Type: OTHER

biopsy placentaire

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LOIC MONDOLONI

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

florence bretelle

Role: CONTACT

florence.bretelle@ap-hm.fr

Facility Contacts

florence bretelle

Role: primary

florence.bretelle@ap-hm.fr

Other Identifiers

2010-04

Identifier Type: OTHER

Identifier Source: secondary_id

2010-A00633-36

Identifier Type: -

Identifier Source: org_study_id