Caesarean Delivery With or Without an Indwelling Bladder Catheter. A Randomised Trial.

October 27, 2021 updated by: University of Aarhus

Caesarean Delivery With or Without an Indwelling Bladder Catheter.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 compelling(1). 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 pain/discomfort due to catheterization and/or with first voiding. Furthermore, the women with an indwelling catheter had longer time to ambulation and longer hospital stay. None of the included studies (n=3) 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 (0.58%), P<0.05). In retrospective studies on women undergoing CD with an indwelling catheter, the overall prevalence of bladder injuries is found to be around 0.3%(6, 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 5.7% incidence of UTI in the catheter group and 0.5% in the non-catheter group(4). With an alpha of 0.05 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 (0.3%). 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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Randers, Denmark, 8930
        • The Region Hospital of Randers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Elective caesarean section (CD). At least 18 years of age.

Exclusion Criteria:

  • Antibiotic therapy less than one week before caesarean and ≥ 3 prior CDs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Without placement of a catheter
Without preoperatively placement of an indwelling catheter during Caesarean section
Procedure: Without placement of a catheter
Elective cesarean section without preoperative placement of a urinary catheter.
Active Comparator: With placement of a catheter
Normal pre-operative routines with placement of an indwelling catheter during Caesarean section
Procedure: With placement of a catheter
Elective cesarean section with preoperative placement of a urinary catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of urinary tract infection (UTI).
Time Frame: 3 days
Urine culture (second day post partum) yielding greater than 105 CFU/ml (of one type of bacteria). Symptoms of UTI include dysuria, urgency and frequency.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of UTI later than second day postpartum
Time Frame: 30 days
UTI verified by a positive culture and/or treatment for UTI initiated by a general practitioner
30 days
Any need for catheterization due to postoperative urinary retention
Time Frame: 24 hours
Any need for catheterization due to postoperative urinary retention
24 hours
Postpartum blood loss >1000 mL.
Time Frame: 4 hours
Postpartum blood loss >1000 mL.
4 hours
Time to ambulation
Time Frame: Up until 48 hours
From time of birth and until standing or walking
Up until 48 hours
Length of hospital stay
Time Frame: Up until 7 days
From time of birth and until discharge.
Up until 7 days
Intraoperative laceration of the bladder
Time Frame: 7 days
Laceration of bladder during surgery
7 days
The incidence of preoperative bacteria in urineculture
Time Frame: 1 day
Positive urine culture preoperatively
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Randers Regional Hospital

Investigators

  • Study Chair: Pinar Bor, MD, Ph.D., Aarhus University and the Region Hospital of Randers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2018

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

March 26, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-113-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not yet discussed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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