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

Catheter-Related Infections Clinical Trial

Official title:

Caesarean Delivery With or Without an Indwelling Bladder Catheter.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03479931
• Other study ID #: 1-10-72-113-17
• Status: Terminated
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: June 1, 2018

Study information

• Verified date: September 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Catheter-Related Infections
• Cesarean Section; Infection
• Communicable Diseases
• Infections

Intervention

Procedure:
• Without placement of a catheter
Elective cesarean section without preoperative placement of a urinary catheter.
• With placement of a catheter
Elective cesarean section with preoperative placement of a urinary catheter.

Locations

Country	Name	City	State
Denmark	The Region Hospital of Randers	Randers

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Randers Regional Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (9)

Abdel-Aleem H, Aboelnasr MF, Jayousi TM, Habib FA. Indwelling bladder catheterisation as part of intraoperative and postoperative care for caesarean section. Cochrane Database Syst Rev. 2014 Apr 11;(4):CD010322. doi: 10.1002/14651858.CD010322.pub2. Review — View Citation

Ghoreishi J. Indwelling urinary catheters in cesarean delivery. Int J Gynaecol Obstet. 2003 Dec;83(3):267-70. — View Citation

Hansen BS, Søreide E, Warland AM, Nilsen OB. Risk factors of post-operative urinary retention in hospitalised patients. Acta Anaesthesiol Scand. 2011 May;55(5):545-8. doi: 10.1111/j.1399-6576.2011.02416.x. Epub 2011 Mar 21. — View Citation

Mulder FE, Schoffelmeer MA, Hakvoort RA, Limpens J, Mol BW, van der Post JA, Roovers JP. Risk factors for postpartum urinary retention: a systematic review and meta-analysis. BJOG. 2012 Nov;119(12):1440-6. doi: 10.1111/j.1471-0528.2012.03459.x. Epub 2012 — View Citation

Nasr AM, ElBigawy AF, Abdelamid AE, Al-Khulaidi S, Al-Inany HG, Sayed EH. Evaluation of the use vs nonuse of urinary catheterization during cesarean delivery: a prospective, multicenter, randomized controlled trial. J Perinatol. 2009 Jun;29(6):416-21. doi — View Citation

Oliphant SS, Bochenska K, Tolge ME, Catov JM, Zyczynski HM. Maternal lower urinary tract injury at the time of Cesarean delivery. Int Urogynecol J. 2014 Dec;25(12):1709-14. doi: 10.1007/s00192-014-2446-2. Epub 2014 Jun 26. — View Citation

Phipps MG, Watabe B, Clemons JL, Weitzen S, Myers DL. Risk factors for bladder injury during cesarean delivery. Obstet Gynecol. 2005 Jan;105(1):156-60. — View Citation

Senanayake H. Elective cesarean section without urethral catheterization. J Obstet Gynaecol Res. 2005 Feb;31(1):32-7. — View Citation

Weber DJ, Sickbert-Bennett EE, Gould CV, Brown VM, Huslage K, Rutala WA. Incidence of catheter-associated and non-catheter-associated urinary tract infections in a healthcare system. Infect Control Hosp Epidemiol. 2011 Aug;32(8):822-3. doi: 10.1086/661107 — View Citation

Outcome

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