Ignite Creation Date:
2024-05-06 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03479931
Status:
TERMINATED
Last Update Posted:
2021-11-04
First Post:
2018-03-12
Brief Title:
Caesarean Delivery With or Without an Indwelling Bladder Catheter A Randomised Trial
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Caesarean Delivery With or Without an Indwelling Bladder Catheter
Status:
TERMINATED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to required changes in methods
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to compare the incidence of catheter associated culture-based urinary tract infection UTI after elective CD with or without preoperative placement of a urinary catheter
Detailed Description:
Protokol version 1_01062017 Scientific protocol Caesarean delivery with or without an indwelling bladder catheter A randomised trial
Background In 2015 approximately 20 of all pregnant women gave birth by caesarean delivery CD in Denmark
Preoperative preparations for CD include the placement of an indwelling urinary catheter The rationale behind the procedure is to decrease the risk of surgical injury to a distended bladder and to avoid postoperative urinary retention but the scientific evidence of the benefit to these matters is not compelling1 On the other hand the placement of an indwelling urinary catheter poses a considerable risk of urinary tract infection UTI 2 besides the costs associated with delayed ambulation prolonged hospital stay and catheter associated discomfort to the woman 3 4 A Cochrane review 1 on indwelling bladder catheter versus no catheter inserted at CD found that indwelling bladder catheterization was associated with longer time to first spontaneous voiding and more paindiscomfort due to catheterization andor with first voiding Furthermore the women with an indwelling catheter had longer time to ambulation and longer hospital stay None of the included studies n3 in the review reported on bladder injury nor the prespecified criteria for diagnosing UTI and thus no result on UTI as a primary outcome could be obtained In addition none of the randomized trials on CD with or without an indwelling bladder catheter were carried out in countries with peri-operative procedures and handling of patients similar to those in Europe
In a prospective clinical study 5 there were no bladder injuries in 344 women undergoing elective CD without a catheter UTI was significantly more prevalent in the catheterized group 6 than in the non-catheterized group 058 P005 In retrospective studies on women undergoing CD with an indwelling catheter the overall prevalence of bladder injuries is found to be around 036 7
The aim of this study is to compare the incidence of catheter associated culture- based urinary tract infection UTI after elective CD with or without preoperative placement of a urinary catheter
Statistics Sample size A power calculation was performed based on a 57 incidence of UTI in the catheter group and 05 in the non-catheter group4 With an alpha of 005 and a power of 80 a total of 400 women would have to be included to detect a significant difference in the primary outcome
The association between the placement of an indwelling urinary catheter during caesarean delivery and the outcomes of interest will be explored using an Intention-to-treat ITT analysis The investigators will perform comparative analyses using multivariate logistic regression with calculation of Odds Ratios with 95 confidence intervals with adjustments for significant differences in baseline characteristics Subgroup analyses will be performed according to the number of previous CDs No interim analysis will be performed A local trial steering committee will be appointed
Side effects risks and inconveniences for the project participants
Any inconveniences for the women in the study with providing an extra urinary sample for bacterial culture are very small Women in the indwelling catheter group receive current standard treatment Women without a catheter may have an increased risk of
1 Urinary retention a known side effect to surgical procedures and regional anaesthesia 9 10 The women without an indwelling catheter might have a slightly increased risk of urinary retention but with our postoperative surveillance all cases will be detected and treated in both groups of women
2 Intraoperative bladder injury the overall risk is very low 03 In women suspected of peri-operative bladder injury both with or without an indwelling catheter methylene blue will be installed into the bladder through an indwelling catheter which will serve to identify the leak In case of accidental bladder puncture surgical repair will be performed immediately
On the other hand women without a catheter may have a decreased risk of
1 Urinary tract infection
2 Delayed ambulation
3 Prolonged hospitalization
7 Biological material Urinary samples are collected from the study participants for both urine dipstick analysis and for urine culture After obtaining results from the urine culture it will be destroyed This is standard procedure at the Department of Microbiology
Information from patient records The participants medical records are accessed for information on the predefined outcomes urine test results any voiding difficulties after CD and catheter removal information on the surgery time to ambulation length of hospital stay any sign or symptoms of an infection or fever during hospital stay and if there has been any contact to our department after discharge
Legal considerations The project will be reported to the Danish Data Protection Agency through the joint notifications Region Midtjylland The information collected from the project participants will be protected according to Danish law Lov om behandling af personoplysninger and Sundhedsloven
Basic information name contact information social security number previous medical and pregnancy history is provided by the participants upon inclusion
Financial compensation The project participants will not receive financial compensation for their participation
Participant information and inclusion Contact to potential participants is established at a joint information meeting for women booked for planned CD where verbal and written information about the project will be provided by a project assistant or a midwife from the delivery ward Both the assistant and midwife are informed and taught personally by the trial doctor Thus women will have the opportunity for reflection at least 4 days before making any decision Furthermore the women are offered extended verbal information at the delivery ward where they are welcome to bring an assessor
In any need of further information the women will be given contact information on key persons responsible for the project
All study participants give oral and written consent at the day of the CD after at least 4 days of consideration in accordance with the Declaration of Helsinki and Central Denmark Research Ethics Committee
The women are informed that their consent can be withdrawn at any time
Publication of project results Both positive negative and inconclusive results will be published in international peer-reviewed journals and at the website of the Regional Hospital of Randers
Ethical considerations With this study the investigators hope to evaluate the possible benefits of caesarean delivery without routine placement of an indwelling catheter in order to improve the course for women with a future CD
The investigators do think that the possible knowledge gained from the project will exceed any possible disadvantages experienced by the individual study participants
Information on patient compensation The Patient Compensation Association covers the trial
Background In 2015 approximately 20 of all pregnant women gave birth by caesarean delivery CD in Denmark
Preoperative preparations for CD include the placement of an indwelling urinary catheter The rationale behind the procedure is to decrease the risk of surgical injury to a distended bladder and to avoid postoperative urinary retention but the scientific evidence of the benefit to these matters is not compelling1 On the other hand the placement of an indwelling urinary catheter poses a considerable risk of urinary tract infection UTI 2 besides the costs associated with delayed ambulation prolonged hospital stay and catheter associated discomfort to the woman 3 4 A Cochrane review 1 on indwelling bladder catheter versus no catheter inserted at CD found that indwelling bladder catheterization was associated with longer time to first spontaneous voiding and more paindiscomfort due to catheterization andor with first voiding Furthermore the women with an indwelling catheter had longer time to ambulation and longer hospital stay None of the included studies n3 in the review reported on bladder injury nor the prespecified criteria for diagnosing UTI and thus no result on UTI as a primary outcome could be obtained In addition none of the randomized trials on CD with or without an indwelling bladder catheter were carried out in countries with peri-operative procedures and handling of patients similar to those in Europe
In a prospective clinical study 5 there were no bladder injuries in 344 women undergoing elective CD without a catheter UTI was significantly more prevalent in the catheterized group 6 than in the non-catheterized group 058 P005 In retrospective studies on women undergoing CD with an indwelling catheter the overall prevalence of bladder injuries is found to be around 036 7
The aim of this study is to compare the incidence of catheter associated culture- based urinary tract infection UTI after elective CD with or without preoperative placement of a urinary catheter
Statistics Sample size A power calculation was performed based on a 57 incidence of UTI in the catheter group and 05 in the non-catheter group4 With an alpha of 005 and a power of 80 a total of 400 women would have to be included to detect a significant difference in the primary outcome
The association between the placement of an indwelling urinary catheter during caesarean delivery and the outcomes of interest will be explored using an Intention-to-treat ITT analysis The investigators will perform comparative analyses using multivariate logistic regression with calculation of Odds Ratios with 95 confidence intervals with adjustments for significant differences in baseline characteristics Subgroup analyses will be performed according to the number of previous CDs No interim analysis will be performed A local trial steering committee will be appointed
Side effects risks and inconveniences for the project participants
Any inconveniences for the women in the study with providing an extra urinary sample for bacterial culture are very small Women in the indwelling catheter group receive current standard treatment Women without a catheter may have an increased risk of
1 Urinary retention a known side effect to surgical procedures and regional anaesthesia 9 10 The women without an indwelling catheter might have a slightly increased risk of urinary retention but with our postoperative surveillance all cases will be detected and treated in both groups of women
2 Intraoperative bladder injury the overall risk is very low 03 In women suspected of peri-operative bladder injury both with or without an indwelling catheter methylene blue will be installed into the bladder through an indwelling catheter which will serve to identify the leak In case of accidental bladder puncture surgical repair will be performed immediately
On the other hand women without a catheter may have a decreased risk of
1 Urinary tract infection
2 Delayed ambulation
3 Prolonged hospitalization
7 Biological material Urinary samples are collected from the study participants for both urine dipstick analysis and for urine culture After obtaining results from the urine culture it will be destroyed This is standard procedure at the Department of Microbiology
Information from patient records The participants medical records are accessed for information on the predefined outcomes urine test results any voiding difficulties after CD and catheter removal information on the surgery time to ambulation length of hospital stay any sign or symptoms of an infection or fever during hospital stay and if there has been any contact to our department after discharge
Legal considerations The project will be reported to the Danish Data Protection Agency through the joint notifications Region Midtjylland The information collected from the project participants will be protected according to Danish law Lov om behandling af personoplysninger and Sundhedsloven
Basic information name contact information social security number previous medical and pregnancy history is provided by the participants upon inclusion
Financial compensation The project participants will not receive financial compensation for their participation
Participant information and inclusion Contact to potential participants is established at a joint information meeting for women booked for planned CD where verbal and written information about the project will be provided by a project assistant or a midwife from the delivery ward Both the assistant and midwife are informed and taught personally by the trial doctor Thus women will have the opportunity for reflection at least 4 days before making any decision Furthermore the women are offered extended verbal information at the delivery ward where they are welcome to bring an assessor
In any need of further information the women will be given contact information on key persons responsible for the project
All study participants give oral and written consent at the day of the CD after at least 4 days of consideration in accordance with the Declaration of Helsinki and Central Denmark Research Ethics Committee
The women are informed that their consent can be withdrawn at any time
Publication of project results Both positive negative and inconclusive results will be published in international peer-reviewed journals and at the website of the Regional Hospital of Randers
Ethical considerations With this study the investigators hope to evaluate the possible benefits of caesarean delivery without routine placement of an indwelling catheter in order to improve the course for women with a future CD
The investigators do think that the possible knowledge gained from the project will exceed any possible disadvantages experienced by the individual study participants
Information on patient compensation The Patient Compensation Association covers the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None