Onset of Labor and Metabolomics (GEM-2)

NCT01071668 | Unknown

• 1 other identifier: 09-041
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Keywords

onset of labor; metabolomics; vaginal secretions; urine; blood

Outcome Measures

Primary Outcomes (1)

• comparison between the metabolic patterns of women before and during labor

  one and half year

Secondary Outcomes (3)

• The study also looks at the comparison of metabolic patterns in late pregnancy and postpartum.

  one and half year

• The project will characterize the metabolome in different fluids collected

  one and half year

• 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

  one and half year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre Hospitalier de l'Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vaginal secretions, whole blood and urine are collected

Study Officials

• Jean-Charles Pasquier, MD, PhD

  Centre Hospitalier de l'Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: April 1, 2009
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

CA (1)