Study of the Effect of Eicosanoids on Contractile Activity of Pregnant Human Myometrium in Pathological Situation (EAU2)
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| First Received Date ICMJE | July 14, 2009 | ||||||||
| Last Updated Date | January 15, 2013 | ||||||||
| Start Date ICMJE | May 2009 | ||||||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
effect of eicosanoids on contractile activity of myometrium of pregnant women with pathological situations [ Time Frame: during c-section ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00939744 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of the Effect of Eicosanoids on Contractile Activity of Pregnant Human Myometrium in Pathological Situation | ||||||||
| Official Title ICMJE | Study of the Effect of Eicosanoids on Contractile Activity of Pregnant Human Myometrium in Pathological Situation. | ||||||||
| Brief Summary | 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. |
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| 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.
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: uterus biopsy |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | women who will have a c-section at the CHUS |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | EAU2
Women who will have a c-section at the CHUS |
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| Publications * | Corriveau S, Pasquier JC, Blouin S, Bellabarba D, Rousseau É. Chronic levothyroxine and acute T3 treatments enhance the amplitude and time course of uterine contractions in human. Am J Physiol Endocrinol Metab. 2013 Mar 1;304(5):E478-85. doi: 10.1152/ajpendo.00346.2012. Epub 2012 Dec 18. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 130 | ||||||||
| Estimated Completion Date | March 2014 | ||||||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00939744 | ||||||||
| Other Study ID Numbers ICMJE | 09-040 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Jean-Charles Pasquier, MD, PhD, Universitaire de Sherbrooke | ||||||||
| Study Sponsor ICMJE | Universitaire de Sherbrooke | ||||||||
| Collaborators ICMJE | Fonds de la Recherche en Santé du Québec | ||||||||
| Investigators ICMJE |
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| Information Provided By | Universitaire de Sherbrooke | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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