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

Pregnancy Complication Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762683
• Other study ID #: LIRUSSI-AOI-2011
• Status: Completed
• Phase: N/A
• Start date: April 6, 2012
• Est. completion date: January 15, 2016

Study information

• Verified date: January 2013
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 15, 2016
• Est. primary completion date: January 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pregnancy Complication
• Pregnancy Complications

Intervention

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.

Locations

Country	Name	City	State
France	Clinique Sainte Marthe	Dijon
France	Maternité du CHU de Dijon	Dijon	Bourgogne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 2 months