Ignite Creation Date:
2024-05-05 @ 9:38 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00939575
Status:
UNKNOWN
Last Update Posted:
2015-03-04
First Post:
2009-07-14
Brief Title:
Pre-eclampsia and Metabolomics
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
Feasibility Study to Develop Analysis of the Metabolomics Patterns of Women With Hypertensive Disorders During Pregnancy
Status:
UNKNOWN
Status Verified Date:
2015-03
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-1
Brief Summary:
The hypertensive disorders of pregnancy are the medical complications more prevalent during pregnancy In Canada approximately 1 of pregnancies have complications due to a pre-existing hypertension 5-6 because of hypertension of pregnancy without proteinuria and 1-2 by preeclampsia 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 Our hypothesis is that metabolic patterns in blood and urine of pregnant women who had preeclampsia differ from the metabolomics patterns of patients without preeclampsiaThe 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 women hospitalized for preeclampsia after 20 SA Women in the control group will be matched to women hospitalized for pre-eclampsia according to gestational age at diagnosis of pre-eclampsia maternal age parity ethnicity and body mass index
Blood and urine samples will be taken
Case control
Following the diagnosis of preeclampsia
At each blood test requested by the physician during the follow-up
When the patient will be in labor cervix ripening 5 cm or before the caesarean section
48 hours after delivery
6-8 weeks after delivery
Control group
Following the inclusion as a control in the study
At admission for delivery
When the patient will be in labor dilation 5 cm or before the caesarean section
48 hours after delivery
6-8 weeks after delivery
Methods
The studied population will be women hospitalized for preeclampsia after 20 SA Women in the control group will be matched to women hospitalized for pre-eclampsia according to gestational age at diagnosis of pre-eclampsia maternal age parity ethnicity and body mass index
Blood and urine samples will be taken
Case control
Following the diagnosis of preeclampsia
At each blood test requested by the physician during the follow-up
When the patient will be in labor cervix ripening 5 cm or before the caesarean section
48 hours after delivery
6-8 weeks after delivery
Control group
Following the inclusion as a control in the study
At admission for delivery
When the patient will be in labor dilation 5 cm or before the caesarean section
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