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Micro Array Analysis in Preeclampsia

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Unknown

Conditions

Preeclampsia

Treatments

Other: biopsy placentaire
Other: samples blood

Study type

Interventional

Funder types

Other

Identifiers

NCT01914809
2010-04
2010-A00633-36

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

group with a preeclampsia before 34 SA
Experimental group
Treatment:
Other: samples blood
Other: biopsy placentaire
group with a normal pregnancy
Other group
Treatment:
Other: samples blood
Other: biopsy placentaire

Trial contacts and locations

1

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Central trial contact

florence bretelle

Data sourced from clinicaltrials.gov

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