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Sponsors and Collaborators: |
Universitaire de Sherbrooke Fondation des étoiles |
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Information provided by: | Universitaire de Sherbrooke |
ClinicalTrials.gov Identifier: | NCT00939575 |
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.
Condition |
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Preeclampsia |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Feasibility Study to Develop Analysis of the Metabolomics Patterns of Women With Hypertensive Disorders During Pregnancy. |
Whole blood and urine are collected
Estimated Enrollment: | 50 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Preeclampsia
Women hospitalized for pre-eclampsia after 20 0/7 weeks of gestation. The diagnosis of preeclampsia include a combination of the following criteria: after 20 weeks of gestation in a previously normotensive woman, a diastolic blood pressure > 90 mmHg recorded twice at least four hours apart or > 110 mmHg, with proteinuria > 300 mg/24h or > 30 mg / mmol protein / urinary creatinine in a urine sample or factor (s) serious maternal / fetal (according to SOGC consensus ).
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control
Women will be matched to women with pre-eclampsia according to gestational age at diagnosis of preeclampsia, maternal age (in stratum of 5 years), gender, ethnicity (4 categories: Caucasian, black, Asian and other) and body mass index (5 classes: <20, 20-25, 26-30, 31-35 and <35). Patients of this group should be at low risk of obstetric complications at recruitment and planning to deliver at the CHUS.
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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:
Control group:
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
women who deliver at the CHUS
Inclusion Criteria:
Exclusion Criteria:
Contact: Lise Lavoie | 819-346-1110 ext 13879 | llavoie.chus@ssss.gouv.qc.ca |
Contact: Maryse Berthiaume, PhD | 819 346-1110 ext 13877 | mberthiaume.chus@ssss.gouv.qc.ca |
Canada, Quebec | |
Centre hospitalier de l'Université de Sherbrooke | Recruiting |
Sherbrooke, Quebec, Canada, J1H 5N4 |
Principal Investigator: | Jean-Charles Pasquier, MD, PhD | Centre hospitalier de l'Université de Sherbrooke |
Principal Investigator: | Christiane Auray-Blais, PhD | Centre hospitalier de l'Université de Sherbrooke |
Responsible Party: | Centre Hospitalier de l'Université de Sherbrooke ( Jean-Charles Pasquier ) |
Study ID Numbers: | 08-173 |
Study First Received: | July 14, 2009 |
Last Updated: | July 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00939575 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
preeclampsia, metabolomics, blood, urine |
Hypertension, Pregnancy-Induced Pregnancy Complications Eclampsia |
Pre-Eclampsia Preeclampsia Hypertension |
Hypertension, Pregnancy-Induced Pregnancy Complications Pre-Eclampsia |