Study of the Effect of Eicosanoids on Contractile Activity of Pregnant Human Myometrium in Pathological Situation (EAU2)

This study is currently recruiting participants.
Verified April 2014 by Université de Sherbrooke
Sponsor:
Collaborator:
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Jean-Charles Pasquier, MD, PhD, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00939744
First received: July 14, 2009
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition
Obstetric Labor Complications
Prolonged Pregnancy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of the Effect of Eicosanoids on Contractile Activity of Pregnant Human Myometrium in Pathological Situation.

Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • effect of eicosanoids on contractile activity of myometrium of pregnant women with pathological situations [ Time Frame: during c-section ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • effect of enzymatic inhibitors on contractile activity of myometrium from pregnant women with pathological situations [ Time Frame: during c-section ] [ Designated as safety issue: No ]
  • detection of enzymes from the different pathways [ Time Frame: after c-section ] [ Designated as safety issue: No ]
  • quantification of eicosanoids in different tissues [ Time Frame: after c-section ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

uterus biopsy


Estimated Enrollment: 130
Study Start Date: May 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
EAU2
Women who will have a c-section at the CHUS

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.

  1. new eicosanoids in cumulative dose (8,9-EET, 11,12-EET, 14,15-EET, 20-HETE), and in combination
  2. enzyme inhibitors of the eicosanoids pathway (AUDA, MS-PPOH, DDMS), and the COX and LOX pathways (indomethacin), alone or in combination.
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

women who will have a c-section at the CHUS

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939744

Contacts
Contact: Stéphanie Corriveau, BSc 819 346-1110 ext 13875 stephanie.corriveau@usherbrooke.ca
Contact: Simon Blouin, PhD 819 346-1110 ext 13877 syblouin.chus@ssss.gouv.qc.ca

Locations
Canada, Quebec
Centre hospitalier de l'Université de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Fonds de la Recherche en Santé du Québec
Investigators
Principal Investigator: Jean-Charles Pasquier, MD, PhD Centre hospitalier de l'Université de Sherbrooke
Principal Investigator: Rousseau Éric, PhD Université de Sherbrooke
  More Information

No publications provided by Université de Sherbrooke

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean-Charles Pasquier, MD, PhD, Dr, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT00939744     History of Changes
Other Study ID Numbers: 09-040
Study First Received: July 14, 2009
Last Updated: April 4, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Sherbrooke:
contractile activity
eicosanoids
pregnant women
obstetrics complications

Additional relevant MeSH terms:
Obstetric Labor Complications
Pregnancy, Prolonged
Pregnancy Complications

ClinicalTrials.gov processed this record on April 16, 2014