LXRs, Cholesterol Metabolism and Uterine Dystocia

Terminated

• Conditions: Uterine Inertia; Dystocia
• Interventions: Biological: Whole blood sampling

• Registration Number: NCT01107158
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-14
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-19
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 58

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Whole blood sampling	Control group: these patients have mechanical dystocia; cholesterol metabolism factors are a priori not involved.
Group 2	Whole blood sampling	These patients have uterine dystocia

Primary Outcome Measures

Name	Time	Method
The multi-loci genotype of the target DNA sequence.	Day 1	The polymorphisms of interest are the following SNPs: rs3758673, rs3758674, rs12221497, rs11039155, rs2279238, rs7120118, rs35463555, rs1052533, rs2248949, rs41432149, rs1405655, rs4802703.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes, France