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Clinical Trials/NCT01071668
NCT01071668
Unknown
Not Applicable

Feasibility Study to Develop the Analysis of the Metabolome During the Onset of Labor During Pregnancy

Université de Sherbrooke1 site in 1 country80 target enrollmentApril 2009
ConditionsPregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Université de Sherbrooke
Enrollment
80
Locations
1
Primary Endpoint
comparison between the metabolic patterns of women before and during labor
Last Updated
10 years ago

Overview

Brief Summary

Premature birth is a public health problem and its incidence has recently increased in all developed countries. In Canada, it represented 6.4% of births in 1981 and 7.6% in 2000. In the last decade, the survival rate of premature infants has increased considerably, but neurological vulnerability has not changed. Premature births are the cause of approximately 28% of neonatal mortality in the world and is the major cause of perinatal mortality and morbidity in developed countries.

Approximately 75-80% of preterm births are spontaneous preterm birth. This type of premature birth included the preterm labor and premature rupture of membranes before term. The contractile activity represents one of the fundamental properties of the uterus during pregnancy and childbirth. The abnormalities associated with uterine contractions are the cause of pathological conditions with important consequences for the mother and fetus.

Metabolomics involves a new technology to investigate small molecules that characterize biochemical pathways of interest. The change in concentration levels of these molecules in various biological samples such as urine and blood in the presence of a disease or a patient can be particularly useful for identifying new biomarkers.

The hypothesis of this study is that gestational metabolomes detected in maternal fluids differ according to pathological situations and lead to the initiation of spontaneous labor. The whole research program has two complementary objectives in order to expect a decrease of prematurity: a) better understanding of all the physiological mechanisms leading to prematurity and b) better identification of patients at high risk for a better management of these women.

Detailed Description

Metabolomics involves a new technology using the methods of separation and detection complex to investigate a set of small molecules that characterize biochemical pathways of interest. The change in concentration levels of these molecules in various biological samples such as urine and blood in the presence of a disease or a patient can detect metabolic fingerprints that can be particularly useful for identifying new biomarkers. These will thereafter be quantified and validated by metabolic profiling. To our knowledge, there are few studies on metabolomics and pregnancy. Methods: The studied population will be pregnant women between 20-30 weeks of gestation without any obstetrical complications. Vaginal secretions, blood and urine samples will be taken: * After inclusion in the project * At hospital admission for delivery * During labor Blood and urine sample will also be taken: * 48 hours after delivery * 6-8 weeks after delivery

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
June 2017
Last Updated
10 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jean-Charles Pasquier, MD, PhD

Dr

Université de Sherbrooke

Eligibility Criteria

Inclusion Criteria

  • Women with single pregnancy
  • Adults (\> 18 years old)

Exclusion Criteria

  • Women with a severe congenital fetal malformation
  • Fetal death
  • Preexisting hypertension (ie before 20 weeks of gestation)
  • Anti-phospholipid syndrome
  • Nephropathy, etc.
  • Viral infections (HIV or hepatitis)
  • Women who want an elective Caesarean section are excluded

Outcomes

Primary Outcomes

comparison between the metabolic patterns of women before and during labor

Time Frame: one and half year

Secondary Outcomes

  • The project will characterize the metabolome in different fluids collected(one and half year)
  • The study will compare the metabolome of women with spontaneous onset of labor with that of women with premature rupture of membranes or induction of labor(one and half year)
  • The study also looks at the comparison of metabolic patterns in late pregnancy and postpartum.(one and half year)

Study Sites (1)

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