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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 January 2013 |
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Main ID: |
NCT00939575 |
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Date of registration:
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14/07/2009 |
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Primary sponsor: |
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Public title:
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Pre-eclampsia and Metabolomics
GEM-1 |
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Scientific title:
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Feasibility Study to Develop Analysis of the Metabolomics Patterns of Women With Hypertensive Disorders During Pregnancy. |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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50 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00939575 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Countries of recruitment
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Canada
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Contacts
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Name:
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Christiane Auray-Blais, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre hospitalier de l'Université de Sherbrooke |
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Name:
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Jean-Charles Pasquier, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre hospitalier de l'Université de Sherbrooke |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Preeclampsia
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Primary Outcome(s)
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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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Secondary Outcome(s)
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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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Longitudinal comparison of metabolomics patterns of the same individual
[Time Frame: between diagnosis of preeclampsia and 2 months after delivery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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