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

Not Applicable

Completed

• Conditions: Pregnancy Complication
• Interventions: Other: Myometrium biopsy and blood samples

• Registration Number: NCT01762683
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-06
• Study First Submitted: 2012-05-31
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-08
• Primary Completion: 2016-01-15
• Study Completion: 2016-01-15
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
women entering labour	Myometrium biopsy and blood samples	women entering labour for vaginal delivery and for vaginal delivery
pre-conceptional obesity with a scheduled cesarean section	Myometrium biopsy and blood samples	-
non-obese women with a scheduled cesarean section	Myometrium biopsy and blood samples	-

Primary Outcome Measures

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

Trial Locations

Locations (2)

Clinique Sainte Marthe; 🇫🇷 Dijon, France

Maternité du CHU de Dijon; 🇫🇷 Dijon, Bourgogne, France