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

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Other: myometrium biopsy

• Registration Number: NCT02862886
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Status Verified: 2011-05
• Primary Completion: 2013-01
• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-10
• Last Update Submitted: 2016-08-10
• Study First Posted: 2016-08-11
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
N°1	myometrium biopsy	-

Primary Outcome Measures

Name	Time	Method
simultaneous assays of 4-amino-5-methylamino-2,7-difluorescein (DAF) / Dihydroethidium (DHE) markers by the technique of high pressure liquid chromatography	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)

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France