LXRs, Cholesterol Metabolism and Uterine Dystocia
This study is currently recruiting participants.
Verified March 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01107158
First received: April 14, 2010
Last updated: April 21, 2013
Last verified: March 2013
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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.
| Estimated Enrollment: | 86 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 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 |
| 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: following spontaneous labor, 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
- 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
- non spontaneous labor
- 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
- non french-speaking patient (impossible to correctly inform the patient)
- patient under guardianship
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107158
Contacts
| Contact: Kevin Mouzat, MD | 33.4.66.68.68.41 | kevin.mouzat@chu-nimes.fr |
Locations
| France | |
| Centre Hospitalier Universitaire de Nîmes | Recruiting |
| Nîmes, France, 30029 | |
| Sub-Investigator: Pierre Marès, MD PhD | |
| Sub-Investigator: Serge Lumbroso, MD PhD | |
| Principal Investigator: Kevin Mouzat, MD | |
| Sub-Investigator: Julia Begler, MD | |
| Sub-Investigator: Renaud de Tayrac, MD PhD | |
| Sub-Investigator: Joël Agenor, MD | |
| Sub-Investigator: Denis Dupaigne, MD | |
| Sub-Investigator: Catherine Masson, MD | |
| Sub-Investigator: Guy Masson, MD | |
| Sub-Investigator: Sylvie Ripart, MD | |
| Sub-Investigator: Marie-Laure Tailland, MD | |
| Sub-Investigator: Anne Margarot, MD | |
| Sub-Investigator: Mélanie Cohen, MD | |
| Sub-Investigator: Vincent Letouzey, MD | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
| Principal Investigator: | Kevin Mouzat, PhD | Centre Hospitalier Universitaire de Nîmes |
More Information
No publications provided
| 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: | April 21, 2013 |
| 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 May 19, 2013