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

NCT ID: NCT02862886

Last Updated: 2016-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Brief Summary

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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

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Conditions

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Pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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N°1

Group Type OTHER

myometrium biopsy

Intervention Type OTHER

Interventions

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myometrium biopsy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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LIONNAIS-COUVREUR AOI 2009

Identifier Type: -

Identifier Source: org_study_id

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