Postpartum Urinary Retention With Essential Oils (PURE) (PURE)
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|ClinicalTrials.gov Identifier: NCT03319498|
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : May 21, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Urinary Retention||Other: Peppermint Oil Vapor Other: Mineral Oil Vapor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Controlled Trial|
|Masking:||Double (Participant, Care Provider)|
|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|
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.
- Resolution of Postpartum Urinary Retention [ Time Frame: within 10 minutes after administering study intervention ]Spontaneous bladder voiding of at least 150 milliliters
- 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.
- 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
- 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."
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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|
- 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.
- 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
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
|Contact: Robin L Driver, BSfirstname.lastname@example.org|
|Contact: Theresa Colbert, MSNemail@example.com|
|United States, Ohio|
|Mount Carmel Health System||Recruiting|
|Columbus, Ohio, United States, 43232|
|Contact: Robin L Driver, BS 614-546-3113 firstname.lastname@example.org|
|Contact: Theresa Colbert, MSN email@example.com|
|Principal Investigator:||Robin L Driver, BS||Mount Carmel Health System|
|Responsible Party:||Robin Driver, Principal Investigator, Mount Carmel Health System|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs