Postpartum Urinary Retention With Essential Oils (PURE)

Sponsor
Mount Carmel Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT03319498
Collaborator
(none)
390
1
2
65.9
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Peppermint Oil Vapor
  • Other: Mineral Oil Vapor
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
390 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized Controlled Trial
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Postpartum Urinary Retention With Essential Oils (PURE): A Randomized Control Trial of Essential Oil Vapor to Reduce Urinary Catheterization in Postpartum Women
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Other: 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.

Placebo Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Resolution of Postpartum Urinary Retention [within 10 minutes after administering study intervention]

    Spontaneous bladder voiding of at least 150 milliliters

Secondary Outcome Measures

  1. 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.

  2. 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

  3. 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."

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mount Carmel Health System Columbus Ohio United States 43232

Sponsors and Collaborators

  • Mount Carmel Health System

Investigators

  • Principal Investigator: Robin L Driver, BS, Mount Carmel Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Robin Driver, Principal Investigator, Mount Carmel Health System
ClinicalTrials.gov Identifier:
NCT03319498
Other Study ID Numbers:
  • 170316-1
First Posted:
Oct 24, 2017
Last Update Posted:
May 21, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 21, 2021