LXRs, Cholesterol Metabolism and Uterine Dystocia

Dystocia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01107158
• Other study ID #: AOI/2009/KM-01
• Status: Terminated
• Phase: N/A
• First received: April 14, 2010
• Last updated: November 19, 2015
• Start date: April 2010
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dystocia
• Uterine Inertia

Intervention

Biological:
• Whole blood sampling
Whole blood sampling for SNP polymorphism analysis

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The multi-loci genotype of the target DNA sequence.	The polymorphisms of interest are the following SNPs: rs3758673, rs3758674, rs12221497, rs11039155, rs2279238, rs7120118, rs35463555, rs1052533, rs2248949, rs41432149, rs1405655, rs4802703.	Day 1	No