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

NCT ID: NCT01762683

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-06

Study Completion Date

2016-01-15

Brief Summary

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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

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Conditions

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Pregnancy Complication

Keywords

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pregnancy obesity differentiation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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pre-conceptional obesity with a scheduled cesarean section

Group Type EXPERIMENTAL

Myometrium biopsy and blood samples

Intervention Type OTHER

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.

non-obese women with a scheduled cesarean section

Group Type ACTIVE_COMPARATOR

Myometrium biopsy and blood samples

Intervention Type OTHER

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.

women entering labour

women entering labour for vaginal delivery and for vaginal delivery

Group Type ACTIVE_COMPARATOR

Myometrium biopsy and blood samples

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maternité du CHU de Dijon

Dijon, Bourgogne-Franche-Comté, France

Site Status

Clinique Sainte Marthe

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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LIRUSSI-AOI-2011

Identifier Type: -

Identifier Source: org_study_id