Influence of Preconceptional Obesity on the Myometrial Cells Differentiation Toward a Contractyl Phenotype (ObeDi)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01762683
Recruitment Status : Unknown
Verified January 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : January 8, 2013
Last Update Posted : January 8, 2013
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:
The purpose of this study is to improve the understanding of cellular mecanism involved in delivery disorders in obese women, first by characterizing the hyperplasia phenomenon of myometrail cells induced by inflammatory stimulation (Il-1B), then by studying the role of blood mononuclear cells, of leptine and of obese women sera to interfere with the transition of myometrial cells toward hyperplasia phenotype.

Condition or disease Intervention/treatment Phase
Pregnancy Complication Other: Myometrium biopsy and blood samples Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of Role of Mononuclear Cells of Maternal Peripheric Blood in Human Myometrial Primar Cell Lines Differentiation Toward a Contratyl Phenotype: Influence of Preconceptional Obesity
Study Start Date : April 2012
Estimated Primary Completion Date : November 2013

Intervention Details:
    Other: Myometrium biopsy and blood samples

    The biopsy of myometrium is specially realised for the study in surgical unit after the release of the child, in women with normal pregnancy but necessitating a caesarean.

    The blood samples are realised, specially for the study, either during the medical exam before the ceasarean or specifically for the study.

Primary Outcome Measures :
  1. Measuring the expression level of markers (Gama actine, Desmine, Connexine-43, and Ocytocine receptor) by Westernblotting [ Time Frame: up to 2 months ]
    Demonstrate in vitro the capacity of a Il-1B stimulus to induce the differentiation of the myometrial cells toward a hyperplasia phenotype, and that the answer depends on whether this is cells from normal weight women or obese women before conception.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Informed consent signed
  • Patient affiliated with a social security scheme
  • Patient with normal pregnancy necessitating a cesarean for obstetrical reasons
  • No obvious infectious context

Exclusion Criteria:

  • Obvious inflammatory or autoimmune diseases
  • Suspected or confirmed infectious context, including virale infection VIH, VHC, VHB
  • Coagulation disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01762683

Contact: Marc BARDOU, Pr 380-393-433 ext +33

Maternité du CHU de Dijon Recruiting
Dijon, Bourgogne, France, 21000
Contact: Marc BARDOU, Pr    380-393-433 ext +33   
Contact: Isabelle LE RAY, Md    380-393-223 ext +33   
Principal Investigator: Paul SAGOT, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon Identifier: NCT01762683     History of Changes
Other Study ID Numbers: LIRUSSI-AOI-2011
First Posted: January 8, 2013    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by Centre Hospitalier Universitaire Dijon:

Additional relevant MeSH terms:
Pregnancy Complications
Nutrition Disorders
Body Weight
Signs and Symptoms