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

April 14, 2010
April 14, 2014
April 2010
May 2015   (final data collection date for primary outcome measure)
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.
The genotype comprised of the homozygous of heterozygous status of the target DNA sequence for each of the polymorphisms of interest. [ 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. There is no time frame for such variables. Genotypes don't change with time.
Complete list of historical versions of study NCT01107158 on ClinicalTrials.gov Archive Site
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LXRs, Cholesterol Metabolism and Uterine Dystocia
The Role of Two Nuclear Receptors for Oxysterols as a Molecular Cause of Uterine Dystocia: LXR Alpha and LXR Beta

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.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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

  • Uterine Inertia
  • Dystocia
Biological: Whole blood sampling
Whole blood sampling for SNP polymorphism analysis
  • Group 1
    Control group: these patients have mechanical dystocia; cholesterol metabolism factors are a priori not involved.
    Intervention: Biological: Whole blood sampling
  • Group 2
    These patients have uterine dystocia
    Intervention: Biological: Whole blood sampling
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
86
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Kevin Mouzat, MD 33.4.66.68.68.41 kevin.mouzat@chu-nimes.fr
France
 
NCT01107158
AOI/2009/KM-01
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Kevin Mouzat, PhD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP