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LXRs, Cholesterol Metabolism and Uterine Dystocia

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Terminated
CT.gov ID
NCT01107158
Collaborator
(none)
58
Enrollment
1
Location
66
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Biological: Whole blood sampling

Study Design

Study Type:
Observational
Actual Enrollment :
58 participants
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
Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. The multi-loci genotype of the target DNA sequence. [Day 1]

    The polymorphisms of interest are the following SNPs: rs3758673, rs3758674, rs12221497, rs11039155, rs2279238, rs7120118, rs35463555, rs1052533, rs2248949, rs41432149, rs1405655, rs4802703.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Centre Hospitalier Universitaire de Nîmes Nîmes France 30029

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Kevin Mouzat, PhD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01107158
Other Study ID Numbers:
  • AOI/2009/KM-01
First Posted:
Apr 20, 2010
Last Update Posted:
Nov 20, 2015
Last Verified:
Nov 1, 2015
Additional relevant MeSH terms:
Dystocia
Uterine Inertia

Study Results

No Results Posted as of Nov 20, 2015