Pre-eclampsia and Metabolomics — GEM-1  

Preeclampsia Clinical Trial

Official title: Feasibility Study to Develop Analysis of the Metabolomics Patterns of Women With Hypertensive Disorders During Pregnancy.

Status Active, not recruiting

Clinical Trial 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 preeclampsia.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.

Clinical Trial 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 ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

• NCT number: NCT00939575
• Study type: Observational
• Source: Université de Sherbrooke
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2009
• Completion date: March 2017