NCT01107158

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2015

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2015

Enrollment Period

5.4 years

First QC Date

April 14, 2010

Last Update Submit

November 17, 2025

Conditions

Uterine InertiaDystocia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group 1

Control group: these patients have mechanical dystocia; cholesterol metabolism factors are a priori not involved.

Biological: Whole blood sampling

Group 2

These patients have uterine dystocia

Biological: Whole blood sampling

Interventions

Whole blood samplingBIOLOGICAL

Whole blood sampling for SNP polymorphism analysis

Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, 30029, France

Location

Related Publications (1)

  • Mouzat K, Raoul C, Polge A, Kantar J, Camu W, Lumbroso S. Liver X receptors: from cholesterol regulation to neuroprotection-a new barrier against neurodegeneration in amyotrophic lateral sclerosis? Cell Mol Life Sci. 2016 Oct;73(20):3801-8. doi: 10.1007/s00018-016-2330-y. Epub 2016 Aug 10.

    PMID: 27510420RESULT

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Uterine InertiaDystocia

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Kevin Mouzat, PhD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2010

First Posted

April 20, 2010

Study Start

April 1, 2010

Primary Completion

September 3, 2015

Study Completion

September 3, 2015

Last Updated

November 19, 2025

Record last verified: 2015-11

Locations

FR(1)