Onset of Labor and Metabolomics (GEM-2)

Pregnancy Clinical Trial

— GEM-2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01071668
• Other study ID #: 09-041
• Status: Active, not recruiting
• Phase: N/A
• First received: February 18, 2010
• Last updated: May 11, 2015
• Start date: April 2009
• Est. completion date: June 2017

Study information

• Verified date: May 2015
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

• Lupus,

• Nephropathy, etc.

• Viral infections (HIV or hepatitis)

• Women who want an elective Caesarean section are excluded

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison between the metabolic patterns of women before and during labor		one and half year	No
Secondary	The study also looks at the comparison of metabolic patterns in late pregnancy and postpartum.		one and half year	No
Secondary	The project will characterize the metabolome in different fluids collected		one and half year	No
Secondary	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	No