Micro Array Analysis in Preeclampsia

Preeclampsia Clinical Trial

Official title:

Micro Array Analysis in Preeclampsia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01914809
• Other study ID #: 2010-A00633-36
• Secondary ID: 2010-04
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2011
• Est. completion date: January 25, 2021

Study information

• Verified date: September 2020
• Source: Assistance Publique Hopitaux De Marseille
• Contact: florence bretelle
• Email: florence.bretelle[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 25, 2021
• Est. primary completion date: January 25, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Other:
• samples blood

• biopsy placentaire

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	predictive markers of preeclampsia	blood samples	36 months
Secondary	analysis of placental transcriptional profile.	biopsie placentaire	36 months