- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00939575
Pre-eclampsia and Metabolomics (GEM-1)
Feasibility Study to Develop Analysis of the Metabolomics Patterns of Women With Hypertensive Disorders During Pregnancy.
Study Overview
Status
Conditions
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
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Quebec
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre Hospitalier de l'Université de Sherbrooke
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Case group: 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 pregnancy 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 consensus SOGC).
- Control group: Women will be matched to women with preeclampsia according to gestational age at diagnosis of pre-eclampsia, 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.
Exclusion Criteria:
- Minor patients, patients with post-partum preeclampsia, premature rupture of membranes, a severe congenital fetal malformation, twin pregnancies and fetal death. Patients with underlying diseases taht could be associated with preeclampsia as pre-existing hypertension (ie before 20SA), anti-phospholipid syndrome, lupus, type DM 1-2, nephropathy, etc will be excluded. Patients who have a complication during the pregnancy will be excluded from the control group.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
comparison between the metabolic patterns of women hospitalized for preeclampsia and the control group
Time Frame: between diagnosis of preeclampsia (or equivalent gestational age) and delivery
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between diagnosis of preeclampsia (or equivalent gestational age) and delivery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Longitudinal comparison of metabolomics patterns of the same individual
Time Frame: between diagnosis of preeclampsia and 2 months after delivery
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between diagnosis of preeclampsia and 2 months after delivery
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Compare metabolomics patterns of pregnant women with preeclampsia early (<34 weeks) during pregnancy to those women with pre-eclampsia later during pregnancy (≥34 weeks of gestation).
Time Frame: between diagnosis of preeclampsia and delivery
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between diagnosis of preeclampsia and delivery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christiane Auray-Blais, PhD, Centre Hospitalier de l'Université de Sherbrooke
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-173
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Clinical Trials on Preeclampsia
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MemorialCare Health SystemNot yet recruitingPreeclampsia | Preeclampsia Postpartum | Preeclampsia Severe | Preeclampsia Mild
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Christiana Care Health ServicesActive, not recruitingPre-Eclampsia | Preeclampsia | Preterm | Preeclampsia Severe | Preeclampsia Second Trimester | Preeclampsia Complicating Childbirth | Preeclampsia PuerperiumUnited States
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University Medical Centre LjubljanaCompletedPreeclampsia Postpartum | Preeclampsia SevereSlovenia
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Cedars-Sinai Medical CenterThermoFisher Scientific Brahms Biomarkers FranceCompletedGestational Hypertension | Preeclampsia Severe | Preeclampsia and Eclampsia | Chronic Hypertension in Obstetric Context | Superimposed Pre-Eclampsia | Preeclampsia MildUnited States
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Washington University School of MedicineRecruitingPreeclampsia Postpartum | Preeclampsia SevereUnited States
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Brigham and Women's HospitalCompletedHypertension in Pregnancy | Postpartum | Postpartum Preeclampsia | Gestational Hypertension | Preeclampsia SevereUnited States
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Christiana Care Health ServicesNot yet recruitingPreterm Birth Complication | Preeclampsia Severe | Preeclampsia Second TrimesterUnited States
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AMAG Pharmaceuticals, Inc.TerminatedSevere PreeclampsiaUnited States, Poland, South Africa
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Mpilo Central HospitalCompletedSevere PreeclampsiaZimbabwe