Breath Metabolomics in the Laboring Parturient

NCT04564196 | Terminated

• 1 other identifier: 54731
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Onset and Length Abnormalities

Outcome Measures

Primary Outcomes (1)

• Profile of volatile organic compounds of the breath

  Mass spectrometry analysis of volatile organic compounds of the breath

  Up to 24 hours

Study Arms (2)

Induction of Labor

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.

Procedure: Breath Sample

Spontaneous Labor

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.

Procedure: Breath Sample

Interventions

Breath Sample PROCEDURE

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.

Induction of Labor; Spontaneous Labor

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with presenting for labor at Stanford.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children Hospital

Stanford, California, 94305-5640, United States

Location

Related Publications (8)

• Rattray NJ, Hamrang Z, Trivedi DK, Goodacre R, Fowler SJ. Taking your breath away: metabolomics breathes life in to personalized medicine. Trends Biotechnol. 2014 Oct;32(10):538-48. doi: 10.1016/j.tibtech.2014.08.003. Epub 2014 Aug 29.

  PMID: 25179940 BACKGROUND

• Norwitz ER, Bonney EA, Snegovskikh VV, Williams MA, Phillippe M, Park JS, Abrahams VM. Molecular Regulation of Parturition: The Role of the Decidual Clock. Cold Spring Harb Perspect Med. 2015 Apr 27;5(11):a023143. doi: 10.1101/cshperspect.a023143.

  PMID: 25918180 BACKGROUND

• McLoughlin G. Interventions during pregnancy to prevent preterm birth: An overview of Cochrane systematic reviews. Res Nurs Health. 2020 Apr;43(2):206-207. doi: 10.1002/nur.22005. Epub 2019 Dec 20. No abstract available.

  PMID: 31859369 BACKGROUND

• Wallace MAG, Pleil JD. Evolution of clinical and environmental health applications of exhaled breath research: Review of methods and instrumentation for gas-phase, condensate, and aerosols. Anal Chim Acta. 2018 Sep 18;1024:18-38. doi: 10.1016/j.aca.2018.01.069. Epub 2018 Feb 9.

  PMID: 29776545 BACKGROUND

• Sukul P, Schubert JK, Trefz P, Miekisch W. Natural menstrual rhythm and oral contraception diversely affect exhaled breath compositions. Sci Rep. 2018 Jul 18;8(1):10838. doi: 10.1038/s41598-018-29221-z.

  PMID: 30022081 BACKGROUND

• Nakhleh MK, Haick H, Humbert M, Cohen-Kaminsky S. Volatolomics of breath as an emerging frontier in pulmonary arterial hypertension. Eur Respir J. 2017 Feb 23;49(2):1601897. doi: 10.1183/13993003.01897-2016. Print 2017 Feb.

  PMID: 28232412 BACKGROUND

• Cristescu SM, Kiss R, Hekkert St, Dalby M, Harren FJ, Risby TH, Marczin N; Harefield BIOSTRESS study investigators. Real-time monitoring of endogenous lipid peroxidation by exhaled ethylene in patients undergoing cardiac surgery. Am J Physiol Lung Cell Mol Physiol. 2014 Oct 1;307(7):L509-15. doi: 10.1152/ajplung.00168.2014. Epub 2014 Aug 15.

  PMID: 25128523 BACKGROUND

• Hengelage J, Fowler C, Goldsberry MD, Stockert E, Bekemeyer Z, Lee H, Wagner NM, Sultan P, Carvalho B, Gross ER. Quantification of breath metabolites in labouring versus non-labouring patients: a feasibility study. Br J Anaesth. 2025 Nov;135(5):1373-1375. doi: 10.1016/j.bja.2025.07.081. Epub 2025 Sep 9.

  PMID: 40930875 DERIVED

Study Officials

• Cedar J Fowler, MD/PhD/MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

• Pervez Sultan, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 25, 2020
• Study Start: November 11, 2020
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 24 months following article publication
• Access Criteria: Proposals may be submitted up to 24 months following article publication. These proposals will be only reviewed if those investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. After 24 months, the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be provided later, please contact PI if unable to locate link).

Locations

US (1)