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funding and compounding issues
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The hypothesis is if administration of acetaminophen during labor will reduce the amount of neuraxial pain medication required for comfort. For the study, Acetaminophen or placebo capsules will be administered at the time of neuraxial analgesia placement and then administered every 6 hours until delivery. Overall consumption of neuraxial pain medication will be determined.
Acetaminophen 1000 mg or placebo capsules will be administered at the time of neuraxial analgesia placement and continued every 6 hours until delivery. Vital signs, scores for pain, nausea, itching, and sleepiness will be also obtained. Evaluation of consumption of neuraxial analgesic medication will be included in the final analysis for the differences between the 2 groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acetaminophen | Active Comparator | 1000 mg every 6 hours during labor up to maximum 3 doses |
|
| placebo | Placebo Comparator | placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 4 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | administered every 6 hours by mouth up to 4 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neuraxial Analgesic Drug Consumption Per Hour | subject evaluated every 2 hours with the amount of neuraxial analgesia consumed during that time period. Study med administered up to 24 hours. labor analgesia continue until delivery. | up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter H Pan, MD, MSEE | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
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Subjects were approached after being admitted to the labor and delivery unit of our facility about participation in this clinical trial
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetaminophen | 1000 mg every 6 hours during labor up to maximum 3 doses Acetaminophen: administered every 6 hours by mouth up to 3 doses |
| FG001 | Placebo | placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetaminophen | 1000 mg every 6 hours during labor up to maximum 3 doses Acetaminophen: administered every 6 hours by mouth up to 3 doses |
| BG001 | Placebo | placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Neuraxial Analgesic Drug Consumption Per Hour | subject evaluated every 2 hours with the amount of neuraxial analgesia consumed during that time period. Study med administered up to 24 hours. labor analgesia continue until delivery. | Posted | Mean | Standard Deviation | milliliters | up to 24 hours |
|
information collected up to 24 hours after the initiation of neuraxial analgesia
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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 | Acetaminophen | 1000 mg every 6 hours during labor up to maximum 3 doses Acetaminophen: administered every 6 hours by mouth up to 3 doses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter H. Pan, MD, MSEE | Wake Forest School of Medicine | 336-718-8278 | ppan@wakehealth.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo | Drug |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Placebo | placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses Placebo | 0 | 15 | 0 | 15 | 0 | 15 |
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| Aniline Compounds |
| D000588 | Amines |