Pre-eclampsia and Metabolomics

Preeclampsia Clinical Trial

— GEM-1  

Official title:

Feasibility Study to Develop Analysis of the Metabolomics Patterns of Women With Hypertensive Disorders During Pregnancy.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00939575
• Other study ID #: 08-173
• Status: Active, not recruiting
• Phase: N/A
• First received: July 14, 2009
• Last updated: March 3, 2015
• Start date: March 2009
• Est. completion date: March 2017

Study information

• Verified date: March 2015
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
Canada	Centre hospitalier de l'Université de Sherbrooke	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Fondation des étoiles

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison between the metabolic patterns of women hospitalized for preeclampsia and the control group		between diagnosis of preeclampsia (or equivalent gestational age) and delivery	No
Secondary	Longitudinal comparison of metabolomics patterns of the same individual		between diagnosis of preeclampsia and 2 months after delivery	No
Secondary	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).		between diagnosis of preeclampsia and delivery	No