Ignite Creation Date:
2024-05-05 @ 10:16 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01071668
Status:
UNKNOWN
Last Update Posted:
2015-05-12
First Post:
2010-02-18
Brief Title:
Onset of Labor and Metabolomics GEM-2
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
Feasibility Study to Develop the Analysis of the Metabolome During the Onset of Labor During Pregnancy
Status:
UNKNOWN
Status Verified Date:
2015-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEM-2
Brief Summary:
Premature birth is a public health problem and its incidence has recently increased in all developed countries In Canada it represented 64 of births in 1981 and 76 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None