LXRs, Cholesterol Metabolism and Uterine Dystocia

This study has been terminated.
(Inclusion curve too slow.)
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01107158
First received: April 14, 2010
Last updated: November 19, 2015
Last verified: November 2015

April 14, 2010
November 19, 2015
April 2010
October 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
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
58
October 2015
October 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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01107158
AOI/2009/KM-01
No
Not Provided
Not Provided
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
November 2015

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