Pre-eclampsia and Metabolomics (GEM-1)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fondation des étoiles
Information provided by (Responsible Party):
Jean-Charles Pasquier, MD, PhD, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00939575
First received: July 14, 2009
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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
Preeclampsia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Feasibility Study to Develop Analysis of the Metabolomics Patterns of Women With Hypertensive Disorders During Pregnancy.

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Longitudinal comparison of metabolomics patterns of the same individual [ Time Frame: between diagnosis of preeclampsia and 2 months after delivery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole blood and urine are collected


Estimated Enrollment: 50
Study Start Date: March 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/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.

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
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

women who deliver at the CHUS

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939575

Locations
Canada, Quebec
Centre hospitalier de l'Université de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Fondation des étoiles
Investigators
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
  More Information

No publications provided

Responsible Party: Jean-Charles Pasquier, MD, PhD, Pr, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT00939575     History of Changes
Other Study ID Numbers: 08-173
Study First Received: July 14, 2009
Last Updated: April 4, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Sherbrooke:
preeclampsia, metabolomics, blood, urine

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on July 26, 2014