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NCT03581214 · ClinicalTrials.gov registry record · NA
Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 910
- Enrollment target
NCT03581214 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 910 participants.
The verdict
NCT03581214, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 910 participants
- Enrollment target
Study Summary
Approximately 2/3 of laboring women receive supplemental oxygen (O2) in an attempt to reverse perceived fetal hypoxia on electronic fetal monitoring (EFM). O2 supplementation is most commonly used in patients with Category II EFM, a class of EFM patterns designed in part to identify fetal acidemia. This liberal use of O2 in laboring patients is concerning because hyperoxygenation in infants is associated with adverse outcomes including retinopathy and abnormal neurodevelopment. Furthermore, excess O2 exposure is linked to free radical generation and subsequent oxidative cell damage. This calls for a closer look at the safety of intrauterine O2 exposure. The proposed project explores potential mechanisms for harm with maternal O2 supplementation in laboring patients with Category II EFM. Specifically, this project will determine the effect of O2, compared to room air (RA), on umbilical cord and maternal levels of malondialdehyde (MDA) and 4-hydroxynonenal (4-HNE), markers of free radical-induced oxidative stress. The study will also explore the correlation between urinary and blood markers of oxidative stress. Banked specimens will be used to investigate the potential effect of peripartum O2 exposure on placental oxidative stress in the future.
Interventions
- OTHER Oxygen
- OTHER No oxygen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 910 participants |
| Start Date | 2018-07-15 |
| Est. Completion | 2024-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03581214
The ClinicalTrials.gov registry entry for NCT03581214 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 910 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Oxygen is the first listed.
NCT03581214 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03581214 about?
NCT03581214 is a clinical study titled "Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate". Approximately 2/3 of laboring women receive supplemental oxygen (O2) in an attempt to reverse perceived fetal hypoxia on electronic fetal monitoring (EFM). O2 supplementation is most commonly used in patients with Category II EFM, a class of EFM patterns designed in part to identify fetal acidemia. ...
What is the current status of trial NCT03581214?
This trial is currently completed. It is a NA study. The enrollment target is 910 participants. The study started on 2018-07-15. Estimated completion is 2024-04-01.
What interventions are being tested in trial NCT03581214?
The interventions under investigation include: Oxygen (OTHER), No oxygen (OTHER).
Who is sponsoring clinical trial NCT03581214?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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