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A randomized controlled study will be conducted, with two arms. Postpartum women experiencing urinary retention will be randomized into one of the two following arms:
The purpose of the study is to determine if the use of peppermint oil among postpartum women experiencing urinary retention will increase spontaneous urination and decrease the need for catheterization. A randomized controlled study will be conducted, with two arms. Subjects will be randomized into one of the two following arms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peppermint Oil | Experimental | Subjects will be exposed to vapor of peppermint oil |
|
| Placebo | Placebo Comparator | Subjects will be exposed to vapor of placebo (mineral oil) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peppermint oil vapors | Other | Subjects will be exposed to vapor of peppermint oil |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients With Urinary Retention Resolved | Urinary retention defined as:
Resolution of urinary retention will be achieved if patient spontaneously voids within 10 minutes after exposure to oil | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Spontaneous Urination | Minutes until participant spontaneously voids | 1 hour |
| Volume of Spontaneous Urination | Volume of urine when participant spontaneously voids |
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Inclusion Criteria:
1. 18 years old or older 2. English speaking 3. Admitted to Bethesda North Mom Baby Unit 4. Postpartum 5. Experiencing urinary retention - defined as meeting at least one of the following criteria:
Exclusion Criteria:
Postpartum women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bethesda North Hospital | Cincinnati | Ohio | 45242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peppermint Oil | Subjects will be exposed to vapor of peppermint oil Peppermint oil vapors: Subjects will be exposed to vapor of peppermint oil |
| FG001 | Placebo | Subjects will be exposed to vapor of placebo (mineral oil) Mineral Oil: Subjects will be exposed to vapor of placebo (mineral oil) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peppermint Oil | Subjects will be exposed to vapor of peppermint oil |
| BG001 | Placebo | Subjects will be exposed to vapor of placebo (mineral oil) |
| 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 | Percent of Patients With Urinary Retention Resolved | Urinary retention defined as:
Resolution of urinary retention will be achieved if patient spontaneously voids within 10 minutes after exposure to oil | Posted | Count of Participants | Participants | 10 minutes |
|
from enrollment until end of follow-up, up to 2 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 | Peppermint Oil | Subjects will be exposed to vapor of peppermint oil | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nurse Researcher | TriHealth | 513-569-6191 | Rachel_Baker2@trihealth.com |
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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 | Aug 12, 2025 | Aug 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D008899 | Mineral Oil |
| ID | Term |
|---|---|
| D010577 | Petrolatum |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Mineral Oil |
| Other |
Subjects will be exposed to vapor of placebo (mineral oil) |
|
| 1 hour |
| Incidence of Urinary Catheterization | Whether participant requires urinary catheterization or not | 1 hour |
| Patient Satisfaction | Patient rated satisfaction | 1 hour |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Placebo |
Subjects will be exposed to vapor of placebo (mineral oil) |
|
|
| Secondary | Time to Spontaneous Urination | Minutes until participant spontaneously voids | Not Posted | 1 hour | Participants |
| Secondary | Volume of Spontaneous Urination | Volume of urine when participant spontaneously voids | Not Posted | 1 hour | Participants |
| Secondary | Incidence of Urinary Catheterization | Whether participant requires urinary catheterization or not | Not Posted | 1 hour | Participants |
| Secondary | Patient Satisfaction | Patient rated satisfaction | Not Posted | 1 hour | Participants |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Placebo | Subjects will be exposed to vapor of placebo (mineral oil) | 0 | 7 | 0 | 7 | 0 | 7 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |