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LXRs, Cholesterol Metabolism and Uterine Dystocia

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ClinicalTrials.gov Identifier: NCT01107158
Recruitment Status : Terminated (Inclusion curve too slow.)
First Posted : April 20, 2010
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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
Uterine Inertia Dystocia Biological: Whole blood sampling

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 : April 2010
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. The multi-loci genotype of the target DNA sequence. [ Time Frame: Day 1 ]
    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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107158


Locations
France
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

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01107158     History of Changes
Other Study ID Numbers: AOI/2009/KM-01
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

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