LXRs, Cholesterol Metabolism and Uterine Dystocia

This study is currently recruiting participants.
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01107158
First received: April 14, 2010
Last updated: April 14, 2014
Last verified: March 2014
  Purpose

Despite the fact that a link between cholesterol and the myometrium has been clearly established, no study investigating aspects of cholesterol metabolism and uterine dystocia currently exists. This study is a pilot study whose aim is to test the hypothesis that an association between uterine dystocia and single-nucleotide polymorphisms (SNPs) in the genes coding for the LXRs.


Condition Intervention
Uterine Inertia
Dystocia
Biological: Whole blood sampling

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Role of Two Nuclear Receptors for Oxysterols as a Molecular Cause of Uterine Dystocia: LXR Alpha and LXR Beta

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • The multi-loci genotype of the target DNA sequence. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The polymorphisms of interest are the following SNPs: rs3758673, rs3758674, rs12221497, rs11039155, rs2279238, rs7120118, rs35463555, rs1052533, rs2248949, rs41432149, rs1405655, rs4802703.


Biospecimen Retention:   Samples With DNA

A whole blood sample is taken and DNA extracted using Qiagen kits.


Estimated Enrollment: 86
Study Start Date: April 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Control group: these patients have mechanical dystocia; cholesterol metabolism factors are a priori not involved.
Biological: Whole blood sampling
Whole blood sampling for SNP polymorphism analysis
Group 2
These patients have uterine dystocia
Biological: Whole blood sampling
Whole blood sampling for SNP polymorphism analysis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population represents women undergoing a difficult, stagnating labor due to either physical or uterine dystocia.

Criteria

Inclusion Criteria:

  • Patients undergoing C-section for a dystocia: 2 to 3 hours of stagnation in labor progress are observed (ie no increasing dilation, and uterine contractions less that 3-5 per 10 minutes) in spite of measures taken to overcome dystocia (oxytocin injection and artificial breaking of waters)
  • the child is alive
  • the child does not have apriori known malformations that could interfere with a vaginal birth
  • foetus in cephalic position
  • full term pregnancy (>= 37 weeks of amenorrhea)
  • single birth
  • patient has signed consent
  • patient is affiliated with a social security system

Exclusion Criteria:

  • vaginal birth
  • programmed C-section
  • C-section is chosen because the fetus has a cardia rhythm problem, and there is no stagnation in the labor process
  • multiple pregnancy
  • the child is in a breech position
  • premature birth (<37 weeks amenorrhea)
  • in utero fetal death
  • fetal malformation known before birth that could interfere with a vaginal birth
  • non french-speaking patient (impossible to correctly inform the patient)
  • patient under guardianship
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107158

Contacts
Contact: Kevin Mouzat, MD 33.4.66.68.68.41 kevin.mouzat@chu-nimes.fr

Locations
France
Centre Hospitalier Universitaire de Nîmes Recruiting
Nîmes, France, 30029
Sub-Investigator: Pierre Marès, MD PhD         
Sub-Investigator: Serge Lumbroso, MD PhD         
Principal Investigator: Kevin Mouzat, MD         
Sub-Investigator: Julia Begler, MD         
Sub-Investigator: Renaud de Tayrac, MD PhD         
Sub-Investigator: Joël Agenor, MD         
Sub-Investigator: Denis Dupaigne, MD         
Sub-Investigator: Catherine Masson, MD         
Sub-Investigator: Guy Masson, MD         
Sub-Investigator: Sylvie Ripart, MD         
Sub-Investigator: Marie-Laure Tailland, MD         
Sub-Investigator: Anne Margarot, MD         
Sub-Investigator: Mélanie Cohen, MD         
Sub-Investigator: Vincent Letouzey, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Kevin Mouzat, PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01107158     History of Changes
Other Study ID Numbers: AOI/2009/KM-01
Study First Received: April 14, 2010
Last Updated: April 14, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Dystocia
Uterine Inertia
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on April 15, 2014