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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Centre Hospitalier Universitaire Dijon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01762683
First received: May 31, 2012
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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 Intervention
Pregnancy Complication
Other: Myometrium biopsy and blood samples

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Measuring the expression level of markers (Gama actine, Desmine, Connexine-43, and Ocytocine receptor) by Westernblotting [ Time Frame: up to 2 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762683

Contacts
Contact: Marc BARDOU, Pr 380-393-433 ext +33 Marc.Bardou@u-bourgogne.fr

Locations
France
Maternité du CHU de Dijon Recruiting
Dijon, Bourgogne, France, 21000
Contact: Marc BARDOU, Pr    380-393-433 ext +33    marc.bardou@u-bourgogne.fr   
Contact: Isabelle LE RAY, Md    380-393-223 ext +33    Isabelle.Le-Ray-Ferrieres@u-bourgogne.fr   
Principal Investigator: Paul SAGOT, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01762683     History of Changes
Other Study ID Numbers: LIRUSSI-AOI-2011
Study First Received: May 31, 2012
Last Updated: January 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire Dijon:
pregnancy
obesity
differentiation

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

ClinicalTrials.gov processed this record on September 22, 2014