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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Completed

CT.gov ID

NCT01762683

Collaborator

(none)

Enrollment

Locations

Arms

45.3

Actual Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Complication	Other: Myometrium biopsy and blood samples	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Actual Study Start Date :

Apr 6, 2012

Actual Primary Completion Date :

Jan 15, 2016

Actual Study Completion Date :

Jan 15, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pre-conceptional obesity with a scheduled cesarean section	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.
Active Comparator: non-obese women with a scheduled cesarean section	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.
Active Comparator: women entering labour women entering labour for vaginal delivery and for vaginal delivery	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.

Arm

Intervention/Treatment

Experimental: pre-conceptional obesity with a scheduled cesarean section

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.

Active Comparator: non-obese women with a scheduled cesarean section

Other: Myometrium biopsy and blood samples

Active Comparator: women entering labour

women entering labour for vaginal delivery and for vaginal delivery

Other: Myometrium biopsy and blood samples

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maternité du CHU de Dijon	Dijon	Bourgogne	France	21000
2	Clinique Sainte Marthe	Dijon		France	21000

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT01762683

Other Study ID Numbers:

LIRUSSI-AOI-2011

First Posted:

Jan 8, 2013

Last Update Posted:

Dec 21, 2018

Last Verified:

Jan 1, 2013

Keywords provided by Centre Hospitalier Universitaire Dijon

pregnancy

obesity

differentiation

Additional relevant MeSH terms:

Pregnancy Complications

Obesity

Study Results

No Results Posted as of Dec 21, 2018