NCT01762683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2016

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

3.8 years

First QC Date

May 31, 2012

Last Update Submit

February 5, 2026

Conditions

Pregnancy Complication

Keywords

pregnancyobesitydifferentiation

Outcome Measures

Primary Outcomes (1)

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

    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.

    up to 2 months

Study Arms (3)

pre-conceptional obesity with a scheduled cesarean section

EXPERIMENTAL
Other: Myometrium biopsy and blood samples

non-obese women with a scheduled cesarean section

ACTIVE COMPARATOR
Other: Myometrium biopsy and blood samples

women entering labour

ACTIVE COMPARATOR

women entering labour for vaginal delivery and for vaginal delivery

Other: Myometrium biopsy and blood samples

Interventions

Myometrium biopsy and blood samplesOTHER

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 sectionpre-conceptional obesity with a scheduled cesarean sectionwomen entering labour

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Obvious inflammatory or autoimmune diseases
  • Suspected or confirmed infectious context, including virale infection VIH, VHC, VHB
  • Coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maternité du CHU de Dijon

Dijon, Bourgogne-Franche-Comté, 21000, France

Location

Clinique Sainte Marthe

Dijon, 21000, France

Location

Related Publications (1)

  • Barrichon M, Hadi T, Wendremaire M, Ptasinski C, Seigneuric R, Marcion G, Delignette M, Marchet J, Dumas M, Sagot P, Bardou M, Garrido C, Lirussi F. Dose-dependent biphasic leptin-induced proliferation is caused by non-specific IL-6/NF-kappaB pathway activation in human myometrial cells. Br J Pharmacol. 2015 Jun;172(12):2974-90. doi: 10.1111/bph.13100. Epub 2015 Mar 24.

    PMID: 25653112RESULT

MeSH Terms

Conditions

Pregnancy ComplicationsObesity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2012

First Posted

January 8, 2013

Study Start

April 6, 2012

Primary Completion

January 15, 2016

Study Completion

January 15, 2016

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

FR(2)