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.

Brief Title

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

Official Title

Caesarean Delivery With or Without an Indwelling Bladder Catheter.

Brief Summary

The aim of this study is to compare the incidence of catheter associated culture-based<br /> urinary tract infection (UTI) after elective CD with or without preoperative placement of a<br /> 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 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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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.