Uterine InertiaNCT01107158
LXRs, Cholesterol Metabolism and Uterine Dystocia
An observational study of Uterine Inertia and Dystocia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Inertia, Dystocia
- What is being tested?
- Whole blood sampling
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to 3 Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population represents women undergoing a difficult, stagnating labor due to either physical or uterine dystocia.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Two Nuclear Receptors for Oxysterols as a Molecular Cause of Uterine Dystocia: LXR Alpha and LXR Beta
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.
- Conditions
- Uterine Inertia, Dystocia
- Being tested
- Whole blood sampling
- Medical subject headings
- Uterine Inertia, Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole blood samplingBiological
Whole blood sampling for SNP polymorphism analysis
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Control group: these patients have mechanical dystocia; cholesterol metabolism factors are a priori not involved. Receives: Biological: Whole blood sampling | |
| Group 2 | These patients have uterine dystocia Receives: Biological: Whole blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startApr 2010
- Primary completion3 Sep 2015
- Study completion3 Sep 2015
Why it stopped: Inclusion curve too slow.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine InertiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Mouzat, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107158
- Sponsor's protocol ID
- AOI/2009/KM-01
- Other IDs
- 2009-A00968-49
- Status last verified
- Nov 2015
- First submitted
- 14 Apr 2010
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27510420
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Two Nuclear Receptors for Oxysterols as a Molecular Cause of Uterine Dystocia: LXR Alpha and LXR Beta
- ClinicalTrials.gov ID
- NCT01107158
- Acronym / sponsor ID
- AOI/2009/KM-01
- Conditions
- Uterine Inertia, Dystocia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inclusion curve too slow.
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- 3 Sep 2015 (actual)
- Study completion
- 3 Sep 2015 (actual)
- First posted
- 20 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Biological: Whole blood samplingControl group: these patients have mechanical dystocia; cholesterol metabolism factors are a priori not involved. |
| Group 2 | – | Biological: Whole blood samplingThese patients have uterine dystocia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population represents women undergoing a difficult, stagnating labor due to either physical or uterine dystocia.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole blood samplingWhole blood sampling for SNP polymorphism analysis | Biological | Group 1, Group 2 |
Primary outcome
The multi-loci genotype of the target DNA sequence.
Time frame: Day 1
The polymorphisms of interest are the following SNPs: rs3758673, rs3758674, rs12221497, rs11039155, rs2279238, rs7120118, rs35463555, rs1052533, rs2248949, rs41432149, rs1405655, rs4802703.
Results and safety
The study was stopped early (reason given: Inclusion curve too slow.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 27510420Mouzat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Mouzat, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Inertia and Dystocia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inclusion curve too slow.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The multi-loci genotype of the target DNA sequence. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01107158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.