Breath Metabolomics in the Laboring Parturient

Terminated

• Conditions: Labor Onset and Length Abnormalities
• Interventions: Procedure: Breath Sample

• Registration Number: NCT04564196
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-25
• Study Start: 2020-11-11
• Status Verified: 2023-06
• Primary Completion: 2023-06-06
• Study Completion: 2023-06-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 53

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.

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spontaneous Labor	Breath Sample	Samples will be collected from women who present in spontaneous labor - The parturient will be asked to breathe 2 tidal volume breaths into a single breath collection bag. The breath collection bag will be closed between each breath. The combined 2 tidal volume breaths will count as a single sample. Samples will be taken at the following endpoints: A) End of 1st stage of labor: At completely cervix dilated and prior starting pushing. A total of 1 sample will be taken. B) End of 3rd stage of labor: Immediately (within 30 minutes) of delivery of the neonate. A total of 1 sample will be taken.
Induction of Labor	Breath Sample	Samples collected from women who present for induction of labor. - The parturient will be asked to breathe 2 tidal volume breaths into a single breath collection bag. The breath collection bag will be closed between each breath. The combined 2 tidal volume breaths will count as a single sample. Samples will be collected at the following time points for patients presenting for induction of labor: A) Baseline: At presentation to labor and delivery unit and prior to initiation of augmentation of labor. A total of 1 sample. B) End of 1st stage of labor: At complete cervix dilatation and prior to starting to push. A total of 1 sample will be taken. C) End of 3rd stage of labor: Immediately (within 30 minutes) of delivery of the neonate. A total of 1 sample will be taken.

Primary Outcome Measures

Name	Time	Method
Profile of volatile organic compounds of the breath	Up to 24 hours	Mass spectrometry analysis of volatile organic compounds of the breath

Trial Locations

Locations (1)

Lucile Packard Children Hospital; 🇺🇸 Stanford, California, United States