PregnancySTRESSOXNCT02862886
Study of the Effect of Beta-3 Adrenergic Receptor Agonists on Oxidative Stress and Signalling Pathways Implicated in Remodelling of the Uteroplacental Space: Experimental in Vitro Approach on Myometrial Tissue Explants
A study testing myometrium biopsy in people with Pregnancy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
CHRONOLOGICAL DESCRIPTION OF THE STUDY 1. Information provided to study participants 2. Collection of written informed consent 3. Harvesting of myometrial biopsies 4. Creation of tissue explants using myometrial biopsies 5. Stimulation of the explants with LPS 6. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- myometrium biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to Jan 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Patients with national health insurance cover
- Patients with a normal pregnancy requiring a caesarean section for obstetrical reasons
- No obvious infectious context
Who cannot join
- Obvious inflammatory or autoimmune diseases
- Suspected or confirmed infectious context, including HIV, HCV HBV
- Coagulation disorders
- Preexisting or gestational diabetes
Trial locations and contacts
1 site in 1 country.
About this study
CHRONOLOGICAL DESCRIPTION OF THE STUDY
- Information provided to study participants
- Collection of written informed consent
- Harvesting of myometrial biopsies
- Creation of tissue explants using myometrial biopsies
- Stimulation of the explants with LPS
- Study of the effect of SAR150640 (beta3-adrenergic agonist) on LPS-induced oxidative stress Moreover, demonstrating the ability of beta3-adrenergic receptor agonists to prevent the appearance of oxidative stress and its consequences on tissues, as a complement to previous studies, is an additional argument for the clinical development of this class of pharmaceuticals in the management of threatened premature delivery and labour induction.
- Conditions
- Pregnancy
- Being tested
- myometrium biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myometrium biopsyOther
| Study group | Role | What they receive |
|---|---|---|
| N°1 | Other | Not described Receives: Other: myometrium biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
simultaneous assays of 4-amino-5-methylamino-2,7-difluorescein (DAF) / Dihydroethidium (DHE) markers by the technique of high pressure liquid chromatography
In vitro measurement of the ability of SAR150640 to prevent the release of free radicals (oxidative stress) induced by an inflammatory stimulus on tissue explants of the human myometrium. The level of oxidative stress will be determined using simultaneous assays of DAF/DHE using HPLC. This reference technique for the overall evaluation of oxidative stress is perfectly mastered at the LPPCE (Laboratoire de Physiopathologie et Pharmacologie Cardiovasculaire et Experimentales)
Measured: The biopsy of myometrium is done specifically for this study in a surgical unit after delivery of the child, in women with a normal pregnancy but requiring a caesarean
Secondary outcomes (1)
Characterization of signalling pathways induced by oxidative stress during inflammation
Characterization of the implication of NADPH oxidase (luminometry) and the subunits of NADPH oxidase (gp91, p22fox, p67phox, p47phox, p40phox as well as Rac1/2) and NO synthases (eNOS \& iNOS), as the source of the oxidative stress induced by an inflammatory stimulus, using Western blot
Measured: The biopsy of myometrium is done specifically for this study in a surgical unit after delivery of the child, in women with a normal pregnancy but requiring a caesarean
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startJul 2010
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 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
- NCT02862886
- Sponsor's protocol ID
- LIONNAIS-COUVREUR AOI 2009
- Acronym
- STRESSOX
- Status last verified
- May 2011
- First submitted
- 5 Aug 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Beta-3 Adrenergic Receptor Agonists on Oxidative Stress and Signalling Pathways Implicated in Remodelling of the Uteroplacental Space: Experimental in Vitro Approach on Myometrial Tissue Explants
- ClinicalTrials.gov ID
- NCT02862886
- Acronym / sponsor ID
- STRESSOX / LIONNAIS-COUVREUR AOI 2009
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2013 (actual)
- First posted
- 11 Aug 2016 (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.
CHRONOLOGICAL DESCRIPTION OF THE STUDY
- Information provided to study participants
- Collection of written informed consent
- Harvesting of myometrial biopsies
- Creation of tissue explants using myometrial biopsies
- Stimulation of the explants with LPS
- Study of the effect of SAR150640 (beta3-adrenergic agonist) on LPS-induced oxidative stress Moreover, demonstrating the ability of beta3-adrenergic receptor agonists to prevent the appearance of oxidative stress and its consequences on tissues, as a complement to previous studies, is an additional argument for the clinical development of this class of pharmaceuticals in the management of threatened premature delivery and labour induction.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N°1 | Other | Other: myometrium biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Patients with national health insurance cover
- Patients with a normal pregnancy requiring a caesarean section for obstetrical reasons
- No obvious infectious context
Key exclusion criteria (4 listed)
- Obvious inflammatory or autoimmune diseases
- Suspected or confirmed infectious context, including HIV, HCV HBV
- Coagulation disorders
- Preexisting or gestational diabetes
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 | Other | N°1 |
Primary outcome
simultaneous assays of 4-amino-5-methylamino-2,7-difluorescein (DAF) / Dihydroethidium (DHE) markers by the technique of high pressure liquid chromatography
Time frame: The biopsy of myometrium is done specifically for this study in a surgical unit after delivery of the child, in women with a normal pregnancy but requiring a caesarean
In vitro measurement of the ability of SAR150640 to prevent the release of free radicals (oxidative stress) induced by an inflammatory stimulus on tissue explants of the human myometrium. The level of oxidative stress will be determined using simultaneous assays of DAF/DHE using HPLC. This reference technique for the overall evaluation of oxidative stress is perfectly mastered at the LPPCE (Laboratoire de Physiopathologie et Pharmacologie Cardiovasculaire et Experimentales)
1 secondary outcome
Characterization of signalling pathways induced by oxidative stress during inflammation
Time frame: The biopsy of myometrium is done specifically for this study in a surgical unit after delivery of the child, in women with a normal pregnancy but requiring a caesarean
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 11 Aug 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myometrium biopsy in people with Pregnancy, run by Centre Hospitalier Universitaire Dijon 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 4 inclusion and 4 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 11 Aug 2016. 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 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?
simultaneous assays of 4-amino-5-methylamino-2,7-difluorescein (DAF) / Dihydroethidium (DHE) markers by the technique of high pressure liquid chromatography (time frame: The biopsy of myometrium is done specifically for this study in a surgical unit after delivery of the child, in women with a normal pregnancy but requiring a caesarean). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2016.