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Onset of Labor and Metabolomics (GEM-2) (GEM-2)

2015年5月11日 更新者:Jean-Charles Pasquier, MD, PhD、Université de Sherbrooke

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

未知

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

观察性的

注册 (预期的)

80

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Quebec
      • Sherbrooke、Quebec、加拿大、J1H 5N4
        • Centre Hospitalier de l'Université de Sherbrooke

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

取样方法

非概率样本

研究人群

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

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.

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
one and half year

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年4月1日

初级完成 (预期的)

2017年3月1日

研究完成 (预期的)

2017年6月1日

研究注册日期

首次提交

2010年2月18日

首先提交符合 QC 标准的

2010年2月18日

首次发布 (估计)

2010年2月19日

研究记录更新

最后更新发布 (估计)

2015年5月12日

上次提交的符合 QC 标准的更新

2015年5月11日

最后验证

2015年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 09-041

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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