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临床试验/NCT04564196
NCT04564196终止不适用

Feasibility Study of the Collection of the Breath Metabolome From Healthy Parturients During Labor

Stanford University1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2020年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
53
试验地点
1
主要终点
Profile of volatile organic compounds of the breath

研究概览

简要总结

This is primarily a feasibility study to determine whether quantitative measurement of volatile organic compounds (VOCs) in the breath of parturients undergoing labor is possible.

Aim A: To determine baseline values of breath metabolites and volatile organic compounds (VOCs) in the breath for term pregnant women.

Aim B: To gather preliminary data to determine breath metabolite and volatile organic compound (VOCs) signature change during labor and delivery.

Aim C: Compare the breath metabolite and volatile organic compound (VOCs) signature women undergoing induction compared to spontaneous vaginal deliveries.

详细描述

Breath metabolites, also known as volatile organic compounds (VOC's) are produced during periods of increased stress and as a marker of underlying medical conditions. The goal of this project is to collect VOCs within the breath in the initial stages of delivery in otherwise healthy parturients undergoing induction of labor. In addition to a panel of metabolites, we will obtain information on the 3400 compounds which compose the breath metabolome by gas mass spectrometry technology. This is the first step of a larger planned project to develop specialized panels of breath signatures during labor and delivery in parturients.

We will collect breath samples at bedside and measure metabolites in the laboratory. This is a feasibility study which we will use to determine normal values for a term parturient and changes of VOCs during the course of labor. We will also use this data to construct a power analysis and perform a follow-up study to test whether VOCs are associated with different aspects of pregnancy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Otherwise healthy nulliparous women with singleton term (37-41 weeks) pregnant at least 18 years of age.
  • Presenting for labor (induction of labor and spontaneous labor) at LPHC.

排除标准

  • Participants unable to or refuse to give informed consent
  • Participants that do not understand English or are hearing impaired
  • Medical History: Chronic disease (HTN, diabetes, asthma)
  • Obstetric History during this pregnancy: gestational diabetes, gestational hypertension, pre-eclampsia, Eclampsia
  • Multiple gestation
  • Any significant fetal anomalies
  • Morbid obesity (BMI>50)

结局指标

主要结局

Profile of volatile organic compounds of the breath

时间窗: Up to 24 hours

Mass spectrometry analysis of volatile organic compounds of the breath

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cedar J. Fowler, M.D. / Ph.D / MPH

Clinical Assistant Professor

Stanford University

研究点 (1)

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