LXRs, Cholesterol Metabolism and Uterine Dystocia

This study is currently recruiting participants.

Verified March 2013 by Centre Hospitalier Universitaire de Nīmes

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 14, 2010

Last Updated Date

April 21, 2013

Start Date ^ICMJE

April 2010

Estimated Primary Completion Date

May 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT01107158 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

LXRs, Cholesterol Metabolism and Uterine Dystocia

Official Title ^ICMJE

The Role of Two Nuclear Receptors for Oxysterols as a Molecular Cause of Uterine Dystocia: LXR Alpha and LXR Beta

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

A whole blood sample is taken and DNA extracted using Qiagen kits.

Sampling Method

Non-Probability Sample

Study Population

The study population represents women undergoing a difficult, stagnating labor due to either physical or uterine dystocia.

Condition ^ICMJE

Uterine Inertia
Dystocia

Intervention ^ICMJE

Biological: Whole blood sampling

Whole blood sampling for SNP polymorphism analysis

Study Group/Cohort (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2015

Estimated Primary Completion Date

May 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kevin Mouzat, MD

33.4.66.68.68.41

kevin.mouzat@chu-nimes.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01107158

Other Study ID Numbers ^ICMJE

AOI/2009/KM-01

Has Data Monitoring Committee

Responsible Party

Centre Hospitalier Universitaire de Nīmes

Study Sponsor ^ICMJE

Centre Hospitalier Universitaire de Nīmes

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kevin Mouzat, PhD

Centre Hospitalier Universitaire de Nîmes

Information Provided By

Centre Hospitalier Universitaire de Nīmes

Verification Date

March 2013

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

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