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

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Pregnancy Complication

Treatments

Other: Myometrium biopsy and blood samples

Study type

Interventional

Funder types

Other

Identifiers

NCT01762683
LIRUSSI-AOI-2011

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

38 participants in 3 patient groups

pre-conceptional obesity with a scheduled cesarean section
Experimental group
Treatment:
Other: Myometrium biopsy and blood samples
non-obese women with a scheduled cesarean section
Active Comparator group
Treatment:
Other: Myometrium biopsy and blood samples
women entering labour
Active Comparator group
Description:
women entering labour for vaginal delivery and for vaginal delivery
Treatment:
Other: Myometrium biopsy and blood samples

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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