Clinical trial NCT04564196: Breath Metabolomics in the Laboring Parturient
Official title: Feasibility Study of the Collection of the Breath Metabolome From Healthy Parturients During Labor
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Labor Onset and Length Abnormalities
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with presenting for labor at Stanford.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Profile of volatile organic compounds of the breath
timeFrame: Up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Packard Children Hospital
state: California
Study officials:
affiliation: Stanford University
name: Cedar J Fowler, MD/PhD/MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Pervez Sultan, MD
role: PRINCIPAL_INVESTIGATOR
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