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

Primary Purpose

Pregnancy Complication

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Myometrium biopsy and blood samples
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pregnancy Complication focused on measuring pregnancy, obesity, differentiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Informed consent signed
  • Patient affiliated with a social security scheme
  • In front of for obstetrical reasons to give birth by caesarean section (scheduled caesarean section)
  • Or a woman who is not obese in labour and needs to undergo a cesarean section
  • No obvious infectious context
  • Age > 18 years old

Exclusion Criteria:

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

Sites / Locations

  • Maternité du CHU de Dijon
  • Clinique Sainte Marthe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

pre-conceptional obesity with a scheduled cesarean section

non-obese women with a scheduled cesarean section

women entering labour

Arm Description

women entering labour for vaginal delivery and for vaginal delivery

Outcomes

Primary Outcome Measures

Measuring the expression level of markers (Gama actine, Desmine, Connexine-43, and Ocytocine receptor) by Westernblotting
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.

Secondary Outcome Measures

Full Information

First Posted
May 31, 2012
Last Updated
December 20, 2018
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT01762683
Brief Title
Influence of Preconceptional Obesity on the Myometrial Cells Differentiation Toward a Contractyl Phenotype
Acronym
ObeDi
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 6, 2012 (Actual)
Primary Completion Date
January 15, 2016 (Actual)
Study Completion Date
January 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complication
Keywords
pregnancy, obesity, differentiation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pre-conceptional obesity with a scheduled cesarean section
Arm Type
Experimental
Arm Title
non-obese women with a scheduled cesarean section
Arm Type
Active Comparator
Arm Title
women entering labour
Arm Type
Active Comparator
Arm Description
women entering labour for vaginal delivery and for vaginal delivery
Intervention Type
Other
Intervention Name(s)
Myometrium biopsy and blood samples
Intervention Description
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 Measure Information:
Title
Measuring the expression level of markers (Gama actine, Desmine, Connexine-43, and Ocytocine receptor) by Westernblotting
Description
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.
Time Frame
up to 2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Informed consent signed Patient affiliated with a social security scheme In front of for obstetrical reasons to give birth by caesarean section (scheduled caesarean section) Or a woman who is not obese in labour and needs to undergo a cesarean section No obvious infectious context Age > 18 years old Exclusion Criteria: Obvious inflammatory or autoimmune diseases Suspected or confirmed infectious context, including virale infection VIH, VHC, VHB Coagulation disorders
Facility Information:
Facility Name
Maternité du CHU de Dijon
City
Dijon
State/Province
Bourgogne
ZIP/Postal Code
21000
Country
France
Facility Name
Clinique Sainte Marthe
City
Dijon
ZIP/Postal Code
21000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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