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Clinical Trials/NCT03319498
NCT03319498TerminatedNot Applicable

Postpartum Urinary Retention With Essential Oils (PURE): A Randomized Control Trial of Essential Oil Vapor to Reduce Urinary Catheterization in Postpartum Women

Mount Carmel Health System1 site in 1 country77 target enrollmentStarted: January 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
77
Locations
1
Primary Endpoint
Resolution of Postpartum Urinary Retention

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Mineral Oil Vapor

Placebo Comparator

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.

Intervention: Mineral Oil Vapor (Other)

Peppermint Oil Vapor

Active Comparator

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.

Intervention: Peppermint Oil Vapor (Other)

Outcomes

Primary Outcomes

Resolution of Postpartum Urinary Retention

Time Frame: within 10 minutes after administering study intervention

Spontaneous bladder voiding of at least 150 milliliters

Secondary Outcomes

  • Time to resolution of urinary retention(Within 6 hours of postpartum urinary retention)
  • Volume of urine voided(Within 6 hours of postpartum urinary retention)
  • Patient Satisfaction Level(Within one hour of study intervention administration)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Robin Driver

Principal Investigator

Mount Carmel Health System

Study Sites (1)

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