- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00939744
Study of the Effect of Eicosanoids on Contractile Activity of Pregnant Human Myometrium in Pathological Situation (EAU2)
Study of the Effect of Eicosanoids on Contractile Activity of Pregnant Human Myometrium in Pathological Situation.
Recent studies show that EET and 20-HETE have important biological effects, particularly in the vascular system. The investigators studied the effect of eicosanoids on the gravid rat uterus. The results suggest that 20-HETE had an tocolytics effect on gravid uterus. In the previous study, we demonstrated that the enzymes of the pathway of EET were present in human uterine tissues. Moreover, the addition of an inhibitor of degradation of EET had an tocolytic effect on the human myometrium, as the exogenous addition of 8.9, 14,15-EET and 20-HETE.
Objectives:
Primary objective: To compare the balance of different metabolic pathways of arachidonic acid (AA) of the pregnant human myometrium in pathological situations (preterm labor, uterine atony, prolonged pregnancy).
Specific objectives: i) To study the effect of derived from the AA on in vitro contractile activity of normal and pathological uterine tissues, and ii) detect and quantify the different sub-products of metabolism of AA in the uterine tissues (myometrium, fetal membranes and placenta).
The management of uterine contraction is in the heart of modern obstetrics year, yet the progress made in other specialties, based on the study of smooth muscle have not yet been transposed in obstetrics. A better understanding of systems for regulating the contraction is important in terms of 1) new physiological knowledge, but it could also be the source of 2) modification of strategies to take care of premature delivery (new Tocolytic), or 3) improving the efficiency of uterine muscle during delivery or 4) for treatment of patients with prolonged pregnancy.
Study Overview
Status
Conditions
Detailed Description
It is a clinical study with a slope fundamental aims to examine the metabolic pathways of AA of human myometrium and their functional roles according to their clinical profile divided into three contractile pathological situations - threat of premature delivery, dynamic dystocia, prolonged pregnancy - and two groups of patients at term: a group before work and group work.
The sampling method. After birth, a biopsy will be perform from the lower segment of the uterus. After caesarean sections of membrane and placenta are collected.
The substances studied during isometric tension tests are part of the three degradation pathways of the AA.
- new eicosanoids in cumulative dose (8,9-EET, 11,12-EET, 14,15-EET, 20-HETE), and in combination
- enzyme inhibitors of the eicosanoids pathway (AUDA, MS-PPOH, DDMS), and the COX and LOX pathways (indomethacin), alone or in combination.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Stéphanie Corriveau, BSc
- Phone Number: 13875 819 346-1110
- Email: stephanie.corriveau@usherbrooke.ca
Study Contact Backup
- Name: Simon Blouin, PhD
- Phone Number: 13877 819 346-1110
- Email: syblouin.chus@ssss.gouv.qc.ca
Study Locations
-
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Quebec
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Sherbrooke, Quebec, Canada, J1H 5N4
- Recruiting
- Centre Hospitalier de l'Université de Sherbrooke
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- all women who will have a c-section
Exclusion Criteria:
- induction of labor,
- child with malformation,
- birth weight less than 2500 grams or greater than 4500g
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
EAU2
Women who will have a c-section at the CHUS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
effect of eicosanoids on contractile activity of myometrium of pregnant women with pathological situations
Time Frame: during c-section
|
during c-section
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
effect of enzymatic inhibitors on contractile activity of myometrium from pregnant women with pathological situations
Time Frame: during c-section
|
during c-section
|
detection of enzymes from the different pathways
Time Frame: after c-section
|
after c-section
|
quantification of eicosanoids in different tissues
Time Frame: after c-section
|
after c-section
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rousseau Éric, PhD, Université de Sherbrooke
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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