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Postpartum Urinary Retention With Essential Oils (PURE) (PURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03319498
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Robin Driver, Mount Carmel Health System

Study Description
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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
Urinary Retention Other: Peppermint Oil Vapor Other: Mineral Oil Vapor Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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 : January 1, 2018
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Resolution of Postpartum Urinary Retention [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study participants are postpartum women with urinary retention.
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319498


Contacts
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Contact: Robin L Driver, BS 614.620-6590 rdriver@mchs.com
Contact: Theresa Colbert, MSN 614.309-9325 tcolbert@mchs.com

Locations
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United States, Ohio
Mount Carmel Health System Recruiting
Columbus, Ohio, United States, 43232
Contact: Robin L Driver, BS    614-546-3113    rdriver@mchs.com   
Contact: Theresa Colbert, MSN       tcolbert@mchs.com   
Sponsors and Collaborators
Mount Carmel Health System
Investigators
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Principal Investigator: Robin L Driver, BS Mount Carmel Health System
More Information
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Responsible Party: Robin Driver, Principal Investigator, Mount Carmel Health System
ClinicalTrials.gov Identifier: NCT03319498    
Other Study ID Numbers: 170316-1
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Retention
Urination Disorders
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Peppermint oil
Mineral Oil
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Parasympatholytics
Emollients
Dermatologic Agents