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We will conduct a randomized controlled trial to determine whether the addition of battlefield auricular acupuncture to standard of care is effective for control of postpartum pain for mothers in the immediate post-partum period. Post-partum patients (DoD beneficiaries) 18 years or older, regardless of gravida/parity, who plan to have a childbirth in a hospital setting will be offered the opportunity to participate in the study through PCM referrals and posted advertisements. After a minimum of 6 hours post-vaginal delivery or 24 hours post caesarean section subjects will be given treatment according to their randomization group. Subjects will be assessed on pain control, overall satisfaction with pain management, and the amount of pharmacological pain medications used. Safety of measures will also be assessed to include infection rates, syncope, vertigo, and hypotension.
Screening Visit:
Randomization: Subjects will then be randomized into one of two groups by one of the Research Coordinators using a random number generator:
Visit 1: Will occur after a minimum of 6 hours post vaginal birth (up until hospital discharge) to avoid disturbing maternal infant bonding or a minimum of 24 hours post caesarean section to avoid confounding with the anesthesia:
In hospital data collection: Data will be collected each day until the patient has been discharged from the hospital. Subjects will be contacted either in person or via phone and the hospital stay will vary from patient to patient:
Post hospital discharge: Each day up until 10 days post Visit 1. Subjects will be contacted phone and the following information will be collected:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Standard of Care only | |
| Battlefield Auricular Acupuncture | Experimental | Standard of Care plus Battlefield Auricular Acupuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Battlefield Auricular Acupuncture | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Achieved 50% Sustained Pain Reduction | measured daily from days 0-11. | 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Equivalent Use | morphine equivalent units (total mg) | 12 days |
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THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.
Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Kim, MD | Mike O'Callaghan Federal Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mike O'Callaghan Federal Medical Center | Nellis Air Force Base | Nevada | 89191 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33078388 | Derived | Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3. | |
| 32871021 | Derived | Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Standard of Care only |
| FG001 | Battlefield Auricular Acupuncture | Standard of Care plus Battlefield Auricular Acupuncture Battlefield Auricular Acupuncture |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Standard of Care only |
| BG001 | Battlefield Auricular Acupuncture | Standard of Care plus Battlefield Auricular Acupuncture Battlefield Auricular Acupuncture |
| 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 | Number of Subjects Who Achieved 50% Sustained Pain Reduction | measured daily from days 0-11. | Posted | Number | # of subjects with 50% pain reduction | 12 days |
|
|
12 days
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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 | Standard of Care | Standard of Care only | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Crawford | MOMH | 7025633583 | amanda.j.crawford.ctr@health.mil |
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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 | May 29, 2018 | Jan 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Morphine Equivalent Use | morphine equivalent units (total mg) | Posted | Mean | Standard Deviation | total mg | 12 days |
|
|
|
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Battlefield Auricular Acupuncture | Standard of Care plus Battlefield Auricular Acupuncture Battlefield Auricular Acupuncture | 0 | 37 | 0 | 37 | 0 | 37 |
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