Pregnancy ComplicationObeDiNCT01762683
Influence of Preconceptional Obesity on the Myometrial Cells Differentiation Toward a Contractyl Phenotype
A study testing Myometrium biopsy and blood samples in people with Pregnancy Complication, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
Trial summary
The purpose of this study is to improve the understanding of cellular mecanism involved in delivery disorders in obese women, first by characterizing the hyperplasia phenomenon of myometrail cells induced by inflammatory stimulation (Il-1B), then by studying the role of blood mononuclear cells, of leptine and of obese… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complication
- What is being tested?
- Myometrium biopsy and blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Apr 2012to 15 Jan 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent signed
- Patient affiliated with a social security scheme
- In front of for obstetrical reasons to give birth by caesarean section (scheduled caesarean section)
- Or a woman who is not obese in labour and needs to undergo a cesarean section
- No obvious infectious context
- Age > 18 years old
Who cannot join
- Obvious inflammatory or autoimmune diseases
- Suspected or confirmed infectious context, including virale infection VIH, VHC, VHB
- Coagulation disorders
Trial locations and contacts
2 sites in 1 country.
France2 sites
Maternité du CHU de Dijon
Dijon, Bourgogne-Franche-Comté, 21000
Clinique Sainte Marthe
Dijon, 21000
About this study
Official title: Study of Role of Mononuclear Cells of Maternal Peripheric Blood in Human Myometrial Primar Cell Lines Differentiation Toward a Contratyl Phenotype: Influence of Preconceptional Obesity
The purpose of this study is to improve the understanding of cellular mecanism involved in delivery disorders in obese women, first by characterizing the hyperplasia phenomenon of myometrail cells induced by inflammatory stimulation (Il-1B), then by studying the role of blood mononuclear cells, of leptine and of obese women sera to interfere with the transition of myometrial cells toward hyperplasia phenotype.
- Conditions
- Pregnancy Complication
- Being tested
- Myometrium biopsy and blood samples
- Keywords
- pregnancy, obesity, differentiation
- Medical subject headings
- Pregnancy Complications, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myometrium biopsy and blood samplesOther
The biopsy of myometrium is specially realised for the study in surgical unit after the release of the child, in women with normal pregnancy but necessitating a caesarean.
The blood samples are realised, specially for the study, either during the medical exam before the ceasarean or specifically for the study.
| Study group | Role | What they receive |
|---|---|---|
| pre-conceptional obesity with a scheduled cesarean section | Experimental | Not described Receives: Other: Myometrium biopsy and blood samples |
| non-obese women with a scheduled cesarean section | Active comparator | Not described Receives: Other: Myometrium biopsy and blood samples |
| women entering labour | Active comparator | women entering labour for vaginal delivery and for vaginal delivery Receives: Other: Myometrium biopsy and blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the expression level of markers (Gama actine, Desmine, Connexine-43, and Ocytocine receptor) by Westernblotting
Demonstrate in vitro the capacity of a Il-1B stimulus to induce the differentiation of the myometrial cells toward a hyperplasia phenotype, and that the answer depends on whether this is cells from normal weight women or obese women before conception.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study start6 Apr 2012
- Primary completion15 Jan 2016
- Study completion15 Jan 2016
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 Pregnancy ComplicationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762683
- Sponsor's protocol ID
- LIRUSSI-AOI-2011
- Acronym
- ObeDi
- Status last verified
- Feb 2026
- First submitted
- 31 May 2012
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Barrichon M, Hadi T, Wendremaire M, Ptasinski C, Seigneuric R, Marcion G, Delignette M, Marchet J, Dumas M, Sagot P, Bardou M, Garrido C, Lirussi F. Dose-dependent biphasic leptin-induced proliferation is caused by non-specific IL-6/NF-kappaB pathway activation in human myometrial cells. Br J Pharmacol. 2015 Jun;172(12):2974-90. doi: 10.1111/bph.13100. Epub 2015 Mar 24.
PubMed 25653112
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Role of Mononuclear Cells of Maternal Peripheric Blood in Human Myometrial Primar Cell Lines Differentiation Toward a Contratyl Phenotype: Influence of Preconceptional Obesity
- ClinicalTrials.gov ID
- NCT01762683
- Acronym / sponsor ID
- ObeDi / LIRUSSI-AOI-2011
- Conditions
- Pregnancy Complication
- Keywords
- pregnancy, obesity, differentiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 6 Apr 2012 (actual)
- Primary completion
- 15 Jan 2016 (actual)
- Study completion
- 15 Jan 2016 (actual)
- First posted
- 8 Jan 2013 (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.
The purpose of this study is to improve the understanding of cellular mecanism involved in delivery disorders in obese women, first by characterizing the hyperplasia phenomenon of myometrail cells induced by inflammatory stimulation (Il-1B), then by studying the role of blood mononuclear cells, of leptine and of obese women sera to interfere with the transition of myometrial cells toward hyperplasia phenotype.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pre-conceptional obesity with a scheduled cesarean section | Experimental | Other: Myometrium biopsy and blood samples |
| non-obese women with a scheduled cesarean section | Active comparator | Other: Myometrium biopsy and blood samples |
| women entering labour | Active comparator | Other: Myometrium biopsy and blood sampleswomen entering labour for vaginal delivery and for vaginal delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent signed
- Patient affiliated with a social security scheme
- In front of for obstetrical reasons to give birth by caesarean section (scheduled caesarean section)
- Or a woman who is not obese in labour and needs to undergo a cesarean section
- No obvious infectious context
Key exclusion criteria (3 listed)
- Obvious inflammatory or autoimmune diseases
- Suspected or confirmed infectious context, including virale infection VIH, VHC, VHB
- Coagulation disorders
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 |
|---|---|---|
| Myometrium biopsy and blood samplesThe biopsy of myometrium is specially realised for the study in surgical unit after the release of the child, in women with normal pregnancy but necessitating a caesarean. The blood samples are realised, specially for the study, either during the medical exam before the ceasarean or specifically for the study. | Other | non-obese women with a scheduled cesarean section, pre-conceptional obesity with a scheduled cesarean section, women entering labour |
Primary outcome
Measuring the expression level of markers (Gama actine, Desmine, Connexine-43, and Ocytocine receptor) by Westernblotting
Time frame: up to 2 months
Demonstrate in vitro the capacity of a Il-1B stimulus to induce the differentiation of the myometrial cells toward a hyperplasia phenotype, and that the answer depends on whether this is cells from normal weight women or obese women before conception.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 25653112Barrichon M, Hadi T, Wendremaire M, Ptasinski C, Seigneuric R, Marcion G, Delignette M, Marchet J, Dumas M, Sagot P, Bardou M, Garrido C, Lirussi F. Dose-dependent biphasic leptin-induced proliferation is caused by non-specific IL-6/NF-kappaB pathway activation in human myometrial cells. Br J Pharmacol. 2015 Jun;172(12):2974-90. doi: 10.1111/bph.13100. Epub 2015 Mar 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myometrium biopsy and blood samples in people with Pregnancy Complication, run by Centre Hospitalier Universitaire Dijon at 2 sites 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measuring the expression level of markers (Gama actine, Desmine, Connexine-43, and Ocytocine receptor) by Westernblotting (time frame: up to 2 months). 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 NCT01762683, 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 9 Feb 2026.