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CompletedNCT02862886STRESSOXUpdated Aug 11, 2016

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

An interventional study of myometrium biopsy in Pregnancy, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-11.

Sponsored by Centre Hospitalier Universitaire Dijon · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.
02

Conditions studied

  • Pregnancy
03

In context

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Obvious inflammatory or autoimmune diseases
  • Suspected or confirmed infectious context, including HIV, HCV HBV
  • Coagulation disorders
  • Preexisting or gestational diabetes
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Other
    N°1

    Other: myometrium biopsy

Interventions

  • Othermyometrium biopsy
06

What researchers measure

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)

    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

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

    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

07

Study locations

1 site
  • CHU Dijon Bourgogne
    Dijon, 21079, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02862886
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Aug 11, 2016
Start date
Jul 2010
Primary completion
Jan 2013
Last update
Aug 11, 2016
View the source record on ClinicalTrials.gov ↗

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