Onset of Labor and Metabolomics (GEM-2) (GEM-2)
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.
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.
研究概览
地位
条件
详细说明
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
研究类型
注册 (预期的)
联系人和位置
学习地点
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Quebec
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Sherbrooke、Quebec、加拿大、J1H 5N4
- Centre Hospitalier de l'Université de Sherbrooke
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
comparison between the metabolic patterns of women before and during labor
大体时间:one and half year
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one and half year
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次要结果测量
结果测量 |
大体时间 |
---|---|
The study also looks at the comparison of metabolic patterns in late pregnancy and postpartum.
大体时间:one and half year
|
one and half year
|
The project will characterize the metabolome in different fluids collected
大体时间:one and half year
|
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
大体时间:one and half year
|
one and half year
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 09-041
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