Labor Onset and Length AbnormalitiesNCT04564196
Breath Metabolomics in the Laboring Parturient
An observational study of Labor Onset and Length Abnormalities, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor Onset and Length Abnormalities
- What is being tested?
- Breath Sample
- Type of treatment
- Surgery or procedure
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2020to 6 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with presenting for labor at Stanford.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children Hospital
Stanford, California, 94305-5640
About this study
Official title: Feasibility Study of the Collection of the Breath Metabolome From Healthy Parturients During Labor
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.
Read the 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.
- Conditions
- Labor Onset and Length Abnormalities
- Being tested
- Breath Sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath SampleProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Breath Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of volatile organic compounds of the breath
Mass spectrometry analysis of volatile organic compounds of the breath
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start11 Nov 2020
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Why it stopped: Staffing and equipment complications have paused further enrollment until resolved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Labor Onset and Length AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cedar J. Fowler, M.D. / Ph.D / MPH, Stanford University
- Investigators
- Cedar J Fowler, MD/PhD/MPH, Principal investigator, Stanford UniversityPervez Sultan, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564196
- Sponsor's protocol ID
- 54731
- Status last verified
- Jun 2023
- First submitted
- 17 Sep 2020
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after publication and deidentification (text, tables, figures, and appendices). The data will be available for individual participant data meta-analysis.
Publications
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.
PubMed 25179940Norwitz 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.
PubMed 25918180McLoughlin 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.
PubMed 31859369Wallace 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.
PubMed 29776545Sukul 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.
PubMed 30022081Nakhleh 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.
PubMed 28232412Cristescu 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.
PubMed 25128523Hengelage 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.
PubMed 40930875
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Collection of the Breath Metabolome From Healthy Parturients During Labor
- ClinicalTrials.gov ID
- NCT04564196
- Acronym / sponsor ID
- 54731
- Conditions
- Labor Onset and Length Abnormalities
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Staffing and equipment complications have paused further enrollment until resolved
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction of Labor | – | Procedure: Breath SampleSamples 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. |
| Spontaneous Labor | – | Procedure: Breath SampleSamples 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with presenting for labor at Stanford.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath Samplebreathe 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. | Procedure or surgery | Induction of Labor, Spontaneous Labor |
Primary outcome
Profile of volatile organic compounds of the breath
Time frame: Up to 24 hours
Mass spectrometry analysis of volatile organic compounds of the breath
Results and safety
The study was stopped early (reason given: Staffing and equipment complications have paused further enrollment until resolved). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Background: PubMed 25179940Rattray 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.
- Background: PubMed 25918180Norwitz 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.
- Background: PubMed 31859369McLoughlin 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.
- Background: PubMed 29776545Wallace 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.
- Background: PubMed 30022081Sukul 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.
- Background: PubMed 28232412Nakhleh 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.
- Background: PubMed 25128523Cristescu 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.
- Derived from this study: PubMed 40930875Hengelage 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after publication and deidentification (text, tables, figures, and appendices). The data will be available for individual participant data meta-analysis.
Related trials for Labor Onset and Length Abnormalities
RecruitingPhase 2
Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial
Labor Onset and Length Abnormalities, First Birth
Recruiting
The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Labor Dystocia, Labor Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cedar J Fowler, MD/PhD/MPH principal investigator
Stanford University
Pervez Sultan, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Onset and Length Abnormalities, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Staffing and equipment complications have paused further enrollment until resolved). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profile of volatile organic compounds of the breath (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04564196, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023; AzTrials last refreshed its copy on 1 Nov 2026.