Breath Metabolomics in the Laboring Parturient

Labor Onset and Length Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04564196
• Other study ID #: 54731
• Status: Terminated
• Start date: November 11, 2020
• Est. completion date: June 6, 2023

Study information

• Verified date: June 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: June 6, 2023
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Congenital Abnormalities
• Labor Onset and Length Abnormalities

Intervention

Procedure:
• Breath Sample
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.

Locations

Country	Name	City	State
United States	Lucile Packard Children Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Profile of volatile organic compounds of the breath	Mass spectrometry analysis of volatile organic compounds of the breath	Up to 24 hours