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

Obstetric Labor Complications Clinical Trial

— EAU2  

Official title:

Study of the Effect of Eicosanoids on Contractile Activity of Pregnant Human Myometrium in Pathological Situation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00939744
• Other study ID #: 09-040
• Status: Recruiting
• Phase: N/A
• First received: July 14, 2009
• Last updated: March 3, 2015
• Start date: May 2009
• Est. completion date: October 2015

Study information

• Verified date: March 2015
• Source: Université de Sherbrooke
• Contact: Stéphanie Corriveau, BSc
• Phone: 819 346-1110
• Email: stephanie.corriveau[@]usherbrooke.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstetric Labor Complications
• Pregnancy, Prolonged
• Prolonged Pregnancy

Locations

Country	Name	City	State
Canada	Centre hospitalier de l'Université de Sherbrooke	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of eicosanoids on contractile activity of myometrium of pregnant women with pathological situations		during c-section	No
Secondary	effect of enzymatic inhibitors on contractile activity of myometrium from pregnant women with pathological situations		during c-section	No
Secondary	detection of enzymes from the different pathways		after c-section	No
Secondary	quantification of eicosanoids in different tissues		after c-section	No