Micro Array Analysis in Preeclampsia

NCT01914809 | Unknown

• 2 other identifiers: 2010-A00633-362010-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• predictive markers of preeclampsia

  blood samples

  36 months

Secondary Outcomes (1)

• analysis of placental transcriptional profile.

  36 months

Study Arms (2)

group with a preeclampsia before 34 SA

EXPERIMENTAL

Other: samples blood; Other: biopsy placentaire

group with a normal pregnancy

OTHER

Other: samples blood; Other: biopsy placentaire

Interventions

samples blood OTHER

group with a normal pregnancy; group with a preeclampsia before 34 SA

biopsy placentaire OTHER

group with a normal pregnancy; group with a preeclampsia before 34 SA

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• LOIC MONDOLONI

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Central Study Contacts

florence bretelle

CONTACT

florence.bretelle@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: August 2, 2013
• Study Start: June 15, 2011
• Primary Completion: January 25, 2021
• Study Completion: January 25, 2021
• Last Updated: September 25, 2020

Record last verified: 2020-09

Locations

FR (1)