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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HD098315-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Room air | Active Comparator | Room air (no mask) |
|
| Oxygen | Placebo Comparator | 10L/min Oxygen by facemask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No oxygen | Other | No facemask, room air only |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Umbilical Artery Malondialdehyde | At delivery | |
| Umbilical Artery 4-hydroxynonenal | At delivery | |
| Maternal Malondialdehyde | Within 1 hour of delivery | |
| Maternal 4-hydroxynonenal | Within 1 hour of delivery |
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Inclusion Criteria:
Exclusion Criteria:
This study is in pregnant females only
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
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910 patients were enrolled. Of these, 698 did not get randomized. This was mostly because they did not ultimately meet randomization criteria (N=669), research staff were not available (N=53), or other logistical reasons (N=33).Of the 910 patients enrolled, 212 were randomized and included in the final analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Room Air | Room air (no mask) No oxygen: No facemask, room air only |
| FG001 | Oxygen | 10L/min Oxygen by facemask Oxygen: 10Liters/minute oxygen by facemask |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Room Air | Room air (no mask) No oxygen: No facemask, room air only |
| BG001 | Oxygen | 10L/min Oxygen by facemask Oxygen: 10Liters/minute oxygen by facemask |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Umbilical Artery Malondialdehyde | Posted | Median | Inter-Quartile Range | umol/L | At delivery |
|
|
72 hours post delivery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Room Air | Room air (no mask) No oxygen: No facemask, room air only | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neonatal ICU stay > 72 hours | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nandini Raghuraman | Washington University in St Louis | 3144548181 | nraghuraman@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2021 | Apr 15, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Oxygen | Other | 10Liters/minute oxygen by facemask |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Insurance | Count of Participants | Participants |
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| Pre-pregnancy obesity | Count of Participants | Participants |
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| Nulliparous | Count of Participants | Participants |
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| Gestational diabetes | Count of Participants | Participants |
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| Chronic Hypertension | Count of Participants | Participants |
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| Induction of labor | Count of Participants | Participants |
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| Oxytocin | Count of Participants | Participants |
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| Epidural | Count of Participants | Participants |
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| Primary | Umbilical Artery 4-hydroxynonenal | Posted | Median | Inter-Quartile Range | pg/ml | At delivery |
|
|
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| Primary | Maternal Malondialdehyde | Posted | Median | Inter-Quartile Range | mmol/L | Within 1 hour of delivery |
|
|
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| Primary | Maternal 4-hydroxynonenal | Posted | Median | Inter-Quartile Range | pg/ml | Within 1 hour of delivery |
|
|
|
| 102 |
| 0 |
| 102 |
| 5 |
| 102 |
| EG001 | Oxygen | 10L/min Oxygen by facemask Oxygen: 10Liters/minute oxygen by facemask | 0 | 104 | 0 | 104 | 3 | 104 |
| Neonatal hypothermia treatment | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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