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

NCT02862886 | Completed

• 1 other identifier: LIONNAIS-COUVREUR AOI 2009
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

CHRONOLOGICAL DESCRIPTION OF THE STUDY

1. 1.Information provided to study participants
2. 2.Collection of written informed consent
3. 3.Harvesting of myometrial biopsies
4. 4.Creation of tissue explants using myometrial biopsies
5. 5.Stimulation of the explants with LPS
6. 6.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

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  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

Study Arms (1)

N°1

OTHER

Other: myometrium biopsy

Interventions

myometrium biopsy OTHER

N°1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Obvious inflammatory or autoimmune diseases
• Suspected or confirmed infectious context, including HIV, HCV HBV
• Coagulation disorders
• Preexisting or gestational diabetes

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 11, 2016
• Study Start: July 1, 2010
• Primary Completion: January 1, 2013
• Last Updated: August 11, 2016

Record last verified: 2011-05

Locations

FR (1)