Postpartum Urinary Retention With Essential Oils (PURE)

Not Applicable

• Conditions: Urinary Retention
• Interventions: Other: Mineral Oil Vapor; Other: Peppermint Oil Vapor

• Registration Number: NCT03319498
• Lead Sponsor: Mount Carmel Health System

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-24
• Study Start: 2018-01-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-18
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 390

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mineral Oil Vapor	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.
Peppermint Oil Vapor	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.

Primary Outcome Measures

Name	Time	Method
Resolution of Postpartum Urinary Retention	within 10 minutes after administering study intervention	Spontaneous bladder voiding of at least 150 milliliters

Secondary Outcome Measures

Name	Time	Method
Time to resolution of urinary retention	Within 6 hours of postpartum urinary retention	Time to resolution of postpartum urinary retention, defined as time from either 6 hours after vaginal delivery or within 6 hours after straight catheter in recovery or 6 hours after catheter removal for cesarean delivery to resolution of postpartum urinary retention.
Volume of urine voided	Within 6 hours of postpartum urinary retention	Volume of urine voided within 10 minutes after study intervention administration, expressed in milliliters
Patient Satisfaction Level	Within one hour of study intervention administration	defined as patient rating of "agree" or "disagree" or "don't know" to the question, "I would recommend this treatment to other patients who cannot empty their bladder after delivering a baby."

Trial Locations

Locations (1)

Mount Carmel Health System; 🇺🇸 Columbus, Ohio, United States