- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01762683
Influence of Preconceptional Obesity on the Myometrial Cells Differentiation Toward a Contractyl Phenotype (ObeDi)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dijon, France, 21000
- Clinique Sainte Marthe
-
-
Bourgogne-Franche-Comté
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Dijon, Bourgogne-Franche-Comté, France, 21000
- Maternité du CHU de Dijon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: pre-conceptional obesity with a scheduled cesarean section
|
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. |
|
Active Comparator: non-obese women with a scheduled cesarean section
|
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. |
|
Active Comparator: women entering labour
women entering labour for vaginal delivery and for vaginal delivery
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to 2 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Nutrition Disorders
- Female Urogenital Diseases and Pregnancy Complications
- Overnutrition
- Body Weight
- Overweight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Pregnancy Complications
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- LIRUSSI-AOI-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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