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Status unknownNCT00939575GEM-1Updated Mar 4, 2015

Pre-eclampsia and Metabolomics

An observational study in Preeclampsia, sponsored by Université de Sherbrooke. Status unknown at 1 site in Canada. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-04.

Sponsored by Université de Sherbrooke · Observational

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 40 Years
Sex
Female
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Study 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.

Read the 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
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Conditions studied

  • Preeclampsia

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Keywords

  • preeclampsia, metabolomics, blood, urine
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In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's planned enrollment of 50 is below the median of 163 across 380 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

women who deliver at the CHUS

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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 ).

  • 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 researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Longitudinal comparison of metabolomics patterns of the same individual

    Time frame: between diagnosis of preeclampsia and 2 months after delivery

  2. 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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Study locations

1 site
  • Centre hospitalier de l'Université de Sherbrooke
    Sherbrooke, Quebec J1H 5N4, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00939575
Lead sponsor
Université de Sherbrooke
Collaborators
Foundation of the Stars
Responsible party
Jean-Charles Pasquier, MD, PhD (Pr, Université de Sherbrooke) — Principal investigator
First posted
Jul 15, 2009
Start date
Mar 2009
Primary completion
Feb 2017 (estimated)
Completion
Mar 2017 (estimated)
Last update
Mar 4, 2015

Study contacts

Jean-Charles Pasquier, MD, PhD
principal investigator · Centre hospitalier de l'Université de Sherbrooke
Christiane Auray-Blais, PhD
principal investigator · Centre hospitalier de l'Université de Sherbrooke

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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