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Trial registered on ANZCTR


Registration number
ACTRN12614000618651
Ethics application status
Approved
Date submitted
2/06/2014
Date registered
11/06/2014
Date last updated
6/03/2020
Date data sharing statement initially provided
27/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Indwelling urinary catheter during epidural anesthesia in labour for preventing postpartum urinary tract infection
Scientific title
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
Secondary ID [1] 284714 0
Nil
Universal Trial Number (UTN)
U1111-1157-5392
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postpartum urinary retention 292072 0
Condition category
Condition code
Reproductive Health and Childbirth 292449 292449 0 0
Childbirth and postnatal care
Renal and Urogenital 292450 292450 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289505 0
Prevention
Comparator / control treatment
Control group (standard care): pregnant women after performing epidural anesthesia as her own request are using intermittent urinary catheter as needed during the course of labor.
Control group
Active

Outcomes
Primary outcome [1] 292274 0
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.
Timepoint [1] 292274 0
Within giving birth 6 hours
Secondary outcome [1] 308609 0
(1) Postpartum urinary retention will be defined if bladder residual volume equal or more than 150 mL by midwives using bladder scanner.
Timepoint [1] 308609 0
After delivery baby 6 hours.
Secondary outcome [2] 308610 0
(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.
Timepoint [2] 308610 0
Within 48 hours of delivery
Secondary outcome [3] 308611 0
(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.
Timepoint [3] 308611 0
Within delivery baby 48 hours, at postpartum department.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All pregnant women who meet the inclusion criteria will be approached for written informed consent by midwives, after they sign the requirement for epidural anesthesia. The midwives will contact with hospital telephone operator to open sealed opaque envelope which contained the allocating treatment has been created by statisticians using block randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization. Participants will be randomized in 2 study group for 1:1 ratio
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome is postpartum urinary retention (PUR) have bladder residual volume (BRV) from and over 400ml. The expected PUR rate with BRV equal or greater than 400ml is 18%. In order to detect the differences between 2 groups is 6%, and cesarean section rate is 20%, we have to rule out cesarean section cases, we need to enrol 738 pregnant women to each arm.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/06/2014
Actual
7/08/2014
Date of last participant enrolment
Anticipated
15/02/2016
Actual
21/11/2015
Date of last data collection
Anticipated
Actual
24/11/2015
Sample size
Target
1500
Accrual to date
Final
1515
Recruitment outside Australia
Country [1] 6092 0
Viet Nam
State/province [1] 6092 0
Ho Chi Minh City

Funding & Sponsors
Funding source category [1] 289339 0
Hospital
Name [1] 289339 0
Hung Vuong hospital
Country [1] 289339 0
Viet Nam
Funding source category [2] 297882 0
Government body
Name [2] 297882 0
Ho Chi Minh City Department of Science and Technology
Country [2] 297882 0
Viet Nam
Primary sponsor type
Individual
Name
Phan Thi Hang
Address
Hung Vuong hospital, 128 Hong Bang street, district 5th, Ho Chi Minh City
Country
Viet Nam
Secondary sponsor category [1] 288026 0
Individual
Name [1] 288026 0
Huynh Nguyen Khanh Trang
Address [1] 288026 0
Ho Chi Minh City of Medicine and Pharmacology University, 217 Hong Bang, district 5th, Ho Chi Minh City
Country [1] 288026 0
Viet Nam
Other collaborator category [1] 279791 0
Individual
Name [1] 279791 0
Tran Son Thach
Address [1] 279791 0
Garvan Institute of Medical Research
384 Victoria Street, Darlinghurst, NSW 2010
Country [1] 279791 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291112 0
Ho Chi Minh City of Medicine and Pharmacy ethics commitee
Ethics committee address [1] 291112 0
Ethics committee country [1] 291112 0
Viet Nam
Date submitted for ethics approval [1] 291112 0
15/01/2014
Approval date [1] 291112 0
27/02/2014
Ethics approval number [1] 291112 0
62/DHYD-HD
Ethics committee name [2] 300142 0
Hung Vuong Hospital
Ethics committee address [2] 300142 0
Ethics committee country [2] 300142 0
Viet Nam
Date submitted for ethics approval [2] 300142 0
03/04/2014
Approval date [2] 300142 0
29/07/2014
Ethics approval number [2] 300142 0
158/QÐ-BVHV

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48902 0
Dr Phan Thi Hang
Address 48902 0
Hung Vuong Hospital, 218 Hong Bang street, district 5th, Ho Chi Minh City
Country 48902 0
Viet Nam
Phone 48902 0
+84908220676
Fax 48902 0
Email 48902 0
phanhangbvhv@yahoo.com
Contact person for public queries
Name 48903 0
Huynh Nguyen Khanh Trang
Address 48903 0
Pham Ngoc Thach University of Medicine
Duong Quang Trung, Ward 12, District 10, Ho Chi Minh City
Country 48903 0
Viet Nam
Phone 48903 0
+84908220676
Fax 48903 0
Email 48903 0
tranghnk08@gmail.com
Contact person for scientific queries
Name 48904 0
Tran Son Thach
Address 48904 0
Garvan Institute of Medical Research
384 Victoria Street, Darlinghurst, NSW 2010
Country 48904 0
Viet Nam
Phone 48904 0
+84908220676
Fax 48904 0
Email 48904 0
th.tran@garvan.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7262Ethical approval    366461-(Uploaded-06-03-2020-02-00-49)-Study-related document.docx
7263Informed consent form    366461-(Uploaded-06-03-2020-01-55-25)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.