Breath Metabolomics in the Laboring Parturient (NCT04564196) | Clinical Trial Compass
TerminatedNot Applicable
Breath Metabolomics in the Laboring Parturient
Stopped: Staffing and equipment complications have paused further enrollment until resolved
United States53 participantsStarted 2020-11-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Profile of volatile organic compounds of the breath