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
  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.

Enrollment: 58
Study Start Date: April 2010
Study Completion Date: October 2015
Primary Completion Date: October 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   (Adult, Senior)
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

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
  More Information

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: November 19, 2015
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 August 25, 2016