Micro Array Analysis in Preeclampsia

Not Applicable

• Conditions: Preeclampsia
• Interventions: Other: samples blood; Other: biopsy placentaire

• Registration Number: NCT01914809
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-15
• Study First Submitted: 2013-07-11
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-09-25
• Primary Completion: 2021-01-25
• Study Completion: 2021-01-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group with a normal pregnancy	biopsy placentaire	-
group with a preeclampsia before 34 SA	samples blood	-
group with a normal pregnancy	samples blood	-
group with a preeclampsia before 34 SA	biopsy placentaire	-

Primary Outcome Measures

Name	Time	Method
predictive markers of preeclampsia	36 months	blood samples

Secondary Outcome Measures

Name	Time	Method
analysis of placental transcriptional profile.	36 months	biopsie placentaire

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France