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Completed

NCT Number: NCT01762683

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maternité du CHU de Dijon, Dijon, Bourgogne-Franche-Comté, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myometrium biopsy and blood samples

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.

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study 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

Acronym: ObeDi

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 8, 2013
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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