Postpartum Urinary Retention With Essential Oils (PURE)

NCT ID: NCT03319498

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2025-12-01

Brief Summary

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The purpose of this study is to examine the effectiveness of peppermint oil to promote voiding and reduce urinary catheterization among postpartum women.

Detailed Description

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Conditions

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Urinary Retention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Peppermint Oil Vapor

Exposure of the perineum to the vapor of the active comparator, 2 ml peppermint oil. The perineum will NOT come into contact with the oil directly.

Group Type ACTIVE_COMPARATOR

Peppermint Oil Vapor

Intervention Type OTHER

2ml of the oil will be placed in the urine collection "hat" that fits into the bowl of the toilet. Participants will then sit on the toilet in normal fashion, exposing their perineum to the vapor of the oil. The perineum will NOT come into contact with the oil directly - only the vapor from the oil will contact the perineum.

Mineral Oil Vapor

Exposure of the perineum to the vapor of the placebo comparator, 2 ml mineral oil. The perineum will NOT come into contact with the oil directly.

Group Type PLACEBO_COMPARATOR

Mineral Oil Vapor

Intervention Type OTHER

2ml of the mineral oil will be placed in the urine collection "hat" that fits into the bowl of the toilet. Participants will then sit on the toilet in normal fashion, exposing their perineum to the vapor of the oil. The perineum will NOT come into contact with the oil directly - only the vapor from the oil will contact the perineum.

Interventions

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Peppermint Oil Vapor

2ml of the oil will be placed in the urine collection "hat" that fits into the bowl of the toilet. Participants will then sit on the toilet in normal fashion, exposing their perineum to the vapor of the oil. The perineum will NOT come into contact with the oil directly - only the vapor from the oil will contact the perineum.

Intervention Type OTHER

Mineral Oil Vapor

2ml of the mineral oil will be placed in the urine collection "hat" that fits into the bowl of the toilet. Participants will then sit on the toilet in normal fashion, exposing their perineum to the vapor of the oil. The perineum will NOT come into contact with the oil directly - only the vapor from the oil will contact the perineum.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* postpartum patients at Mount Carmel East, Mount Carmel West, and Mount Carmel St. Ann's Hospital
* 18 years or older
* able to read and understand English
* unable to spontaneously void within 6 hours after vaginal delivery or within 6 hours after straight catheter or within 6 hours after catheter removal for cesarean delivery.

Exclusion Criteria

* patients who have an allergy to peppermint oil
* patients who have asthma
* patients who report sensitivity to smells
* patients who have a clinical condition which precludes walking/use of standard toilet
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mount Carmel Health System

OTHER

Sponsor Role lead

Responsible Party

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Robin Driver

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robin L Driver, BS

Role: PRINCIPAL_INVESTIGATOR

Mount Carmel Health System

Locations

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Mount Carmel Health System

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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170316-1

Identifier Type: -

Identifier Source: org_study_id

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