NCT00939744

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 4, 2015

Status Verified

March 1, 2015

Enrollment Period

6.2 years

First QC Date

July 14, 2009

Last Update Submit

March 3, 2015

Conditions

Obstetric Labor ComplicationsProlonged Pregnancy

Keywords

contractile activityeicosanoidspregnant womenobstetrics complications

Outcome Measures

Primary Outcomes (1)

  • effect of eicosanoids on contractile activity of myometrium of pregnant women with pathological situations

    during c-section

Secondary Outcomes (3)

  • effect of enzymatic inhibitors on contractile activity of myometrium from pregnant women with pathological situations

    during c-section

  • detection of enzymes from the different pathways

    after c-section

  • quantification of eicosanoids in different tissues

    after c-section

Study Arms (1)

EAU2

Women who will have a c-section at the CHUS

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women who will have a c-section at the CHUS

You may qualify if:

  • all women who will have a c-section

You may not qualify if:

  • induction of labor,
  • child with malformation,
  • birth weight less than 2500 grams or greater than 4500g

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier de l'Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Related Publications (1)

  • Corriveau S, Pasquier JC, Blouin S, Bellabarba D, Rousseau E. 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.

    PMID: 23249699DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

uterus biopsy

MeSH Terms

Conditions

Obstetric Labor ComplicationsPregnancy, Prolonged

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jean-Charles Pasquier, MD, PhD

    Centre hospitalier de l'Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

  • Rousseau Éric, PhD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie Corriveau, BSc

CONTACT

819 346-1110stephanie.corriveau@usherbrooke.ca

Simon Blouin, PhD

CONTACT

819 346-1110syblouin.chus@ssss.gouv.qc.ca

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 15, 2009

Study Start

May 1, 2009

Primary Completion

July 1, 2015

Study Completion

October 1, 2015

Last Updated

March 4, 2015

Record last verified: 2015-03

Locations

CA(1)