PregnancyGEM-2NCT01071668
Onset of Labor and Metabolomics (GEM-2)
An observational study of Pregnancy, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2009to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women between 20-30 weeks of gestation who have a low risk pregnancy.
Who may be able to join
- Women with single pregnancy
- Adults (> 18 years old)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Feasibility Study to Develop the Analysis of the Metabolome During the Onset of Labor During Pregnancy
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.
Read more
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.
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 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
- Conditions
- Pregnancy
- Keywords
- onset of labor, metabolomics, vaginal secretions, urine, blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between the metabolic patterns of women before and during labor
Measured: one and half year
Secondary outcomes (3)
The study also looks at the comparison of metabolic patterns in late pregnancy and postpartum.
Measured: one and half year
The project will characterize the metabolome in different fluids collected
Measured: 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
Measured: one and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startApr 2009
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Charles Pasquier, MD, PhD, Université de Sherbrooke
- Investigators
- Jean-Charles Pasquier, MD, PhD, Principal investigator, Centre Hospitalier de l'Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071668
- Sponsor's protocol ID
- 09-041
- Acronym
- GEM-2
- Status last verified
- May 2015
- First submitted
- 18 Feb 2010
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Develop the Analysis of the Metabolome During the Onset of Labor During Pregnancy
- ClinicalTrials.gov ID
- NCT01071668
- Acronym / sponsor ID
- GEM-2 / 09-041
- Conditions
- Pregnancy
- Keywords
- onset of labor, metabolomics, vaginal secretions, urine, blood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women between 20-30 weeks of gestation who have a low risk pregnancy.
Key inclusion criteria (2 listed)
- Women with single pregnancy
- Adults (> 18 years old)
Key exclusion criteria (8 listed)
- Women with a severe congenital fetal malformation
- Fetal death
- Preexisting hypertension (ie before 20 weeks of gestation)
- Anti-phospholipid syndrome
- Lupus,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
comparison between the metabolic patterns of women before and during labor
Time frame: one and half year
3 secondary outcomes
The study also looks at the comparison of metabolic patterns in late pregnancy and postpartum.
Time frame: one and half year
The project will characterize the metabolome in different fluids collected
Time frame: 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
Time frame: one and half year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Charles Pasquier, MD, PhD principal investigator
Centre Hospitalier de l'Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between the metabolic patterns of women before and during labor (time frame: one and half year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.