Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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16 March 2020 |
Main ID: |
ACTRN12614000618651 |
Date of registration:
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11/06/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Indwelling urinary catheter during epidural anesthesia in labour for preventing postpartum urinary tract infection
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Scientific title:
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Randomized control trial of continuous indwelling urinary catheter versus intermittent urinary catheter in pregnant women during epidural anesthesia in labour to prevent severe post partum urinary retention |
Date of first enrolment:
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07/08/2014 |
Target sample size:
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1500 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12614000618651.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Viet Nam
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Contacts
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Name:
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Dr Tran Son Thach
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Address:
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Garvan Institute of Medical Research
384 Victoria Street, Darlinghurst, NSW 2010
Viet Nam |
Telephone:
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+84908220676 |
Email:
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th.tran@garvan.org.au |
Affiliation:
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Name:
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Dr Huynh Nguyen Khanh Trang
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Address:
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Pham Ngoc Thach University of Medicine
Duong Quang Trung, Ward 12, District 10, Ho Chi Minh City
Viet Nam |
Telephone:
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+84908220676 |
Email:
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tranghnk08@gmail.com |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Pregnant women have singleton pregnancy, head presentation admit to Hung Vuong hospital, and who are anticipated to undergo vaginal delivery during current condition and
require epidural anesthesia during labor.
Exclusion criteria: Women pregnant have planned cesarean section
Previous Cesarean section
Women have indication for indwelling urinary catheter postpartum such as: severe preeclampsia, eclampsia, severe postpartum haemorrhage, sever internal medical diseases
Women have urinary tract infection within 2 weeks of admission
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Reproductive Health and Childbirth - Childbirth and postnatal care
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Postpartum urinary retention; Postpartum urinary retention
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Renal and Urogenital - Other renal and urogenital disorders
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Intervention(s)
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Epidural anesthesia for pain control during labor is know to inhibit natural voiding and is high risk factor for postpartum urinary retention. There has not enough evidence to help Obstetricians and Midwives choose indwelling urinary catheter or intermittent straight urinary catheter for bladder care during labor. The aim of this study is to know does indwelling urinary catheter help to reduce the rate of postpartum urinary retention for women who have epidural anesthesia and vaginal delivery. Intervention group: pregnant women after performing epidural anesthesia as her own request, indwelling urinary catheter will be kept in place until the time of delivery.
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Primary Outcome(s)
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Midwives will measure bladder residual volume by bladder scanner. Severe postpartum urinary retention will be diagnosed if bladder residual volume equal or more than 400mL. [Within giving birth 6 hours]
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Secondary Outcome(s)
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(2) Urinary tract infection is identified if pregnant women have the symptoms of urinary tract infection and have positive microbiology culture result. The symptoms of UTI are complained by women or doctors ask information include one of those: fever, dysuria, voiding urgency, frequency, subrapubic tenderness, costovertebral angle pain.[Within 48 hours of delivery]
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(1) Postpartum urinary retention will be defined if bladder residual volume equal or more than 150 mL by midwives using bladder scanner.[After delivery baby 6 hours.]
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(3): Satisfaction of pregnant women during labor with epidural anesthesia and her feeling of bladder care during labor (indwelling or intermittent urinary catheter), using five - point Likert scale.[Within delivery baby 48 hours, at postpartum department.]
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Source(s) of Monetary Support
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Hung Vuong hospital
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Ho Chi Minh City Department of Science and Technology
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Ethics review
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Status: Approved
Approval date: 27/02/2014
Contact:
Ho Chi Minh City of Medicine and Pharmacy ethics commitee
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Status: Approved
Approval date: 29/07/2014
Contact:
Hung Vuong Hospital
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Results
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Results available:
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Yes |
Date Posted:
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27/02/2019 |
Date Completed:
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24/11/2015 |
URL:
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