LXRs, Cholesterol Metabolism and Uterine Dystocia

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 16, 2014