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Onset of Labor and Metabolomics (GEM-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jean-Charles Pasquier, MD, PhD, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01071668
First received: February 18, 2010
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

Premature birth is a public health problem and its incidence has recently increased in all developed countries. In Canada, it represented 6.4% of births in 1981 and 7.6% in 2000. In the last decade, the survival rate of premature infants has increased considerably, but neurological vulnerability has not changed. Premature births are the cause of approximately 28% of neonatal mortality in the world and is the major cause of perinatal mortality and morbidity in developed countries.

Approximately 75-80% of preterm births are spontaneous preterm birth. This type of premature birth included the preterm labor and premature rupture of membranes before term. The contractile activity represents one of the fundamental properties of the uterus during pregnancy and childbirth. The abnormalities associated with uterine contractions are the cause of pathological conditions with important consequences for the mother and fetus.

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.

The hypothesis of this study is that gestational metabolomes detected in maternal fluids differ according to pathological situations and lead to the initiation of spontaneous labor. 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
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility Study to Develop the Analysis of the Metabolome During the Onset of Labor During Pregnancy

Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • comparison between the metabolic patterns of women before and during labor [ Time Frame: one and half year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The study also looks at the comparison of metabolic patterns in late pregnancy and postpartum. [ Time Frame: one and half year ] [ Designated as safety issue: No ]
  • The project will characterize the metabolome in different fluids collected [ Time Frame: one and half year ] [ Designated as safety issue: No ]
  • The study will compare the metabolome of women with spontaneous onset of labor with that of women with premature rupture of membranes or induction of labor [ Time Frame: one and half year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Vaginal secretions, whole blood and urine are collected


Estimated Enrollment: 80
Study Start Date: April 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
GEM-2 Cohort
Women who have a low risk pregnancy before onset of labor. Patients included in the study who will be hospitalized with spontaneous labor at term with intact membranes or preterm labor will be included in the study group. Patients with premature rupture of membranes or induction of labor will be analyzed separately.

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 pregnant women between 20-30 weeks of gestation without any obstetrical complications.

Vaginal secretions, blood and urine samples will be taken:

  • After inclusion in the project
  • At hospital admission for delivery
  • During labor

Blood and urine sample will also be taken:

  • 48 hours after delivery
  • 6-8 weeks after delivery
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women between 20-30 weeks of gestation who have a low risk pregnancy.

Criteria

Inclusion Criteria:

  • Women with single pregnancy
  • Adults (> 18 years old)

Exclusion Criteria:

  • Women with a severe congenital fetal malformation
  • Fetal death
  • Preexisting hypertension (ie before 20 weeks of gestation)
  • Anti-phospholipid syndrome
  • Lupus,
  • Nephropathy, etc.
  • Viral infections (HIV or hepatitis)
  • Women who want an elective Caesarean section are excluded
  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: NCT01071668

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Jean-Charles Pasquier, MD, PhD Centre Hospitalier de l'Université de Sherbrooke
  More Information

No publications provided

Responsible Party: Jean-Charles Pasquier, MD, PhD, Dr, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01071668     History of Changes
Other Study ID Numbers: 09-041
Study First Received: February 18, 2010
Last Updated: April 4, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Sherbrooke:
onset of labor
metabolomics
vaginal secretions
urine
blood

ClinicalTrials.gov processed this record on November 20, 2014