Caesarean Delivery With or Without an Indwelling Bladder Catheter
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2018
CompletedFirst Posted
Study publicly available on registry
September 14, 2018
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedApril 25, 2019
September 1, 2018
4 years
September 13, 2018
April 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of urinary tract infection (UTI).
Urine culture (second day post partum) yielding ≥ 10\*5 CFU/ml (of one type of bacteria).
3 days
Secondary Outcomes (7)
The incidence of UTI later than second day postpartum
30 days
Any need for catheterization due to postoperative urinary retention
24 hours
Postpartum blood loss >1000 mL.
4 hours
Time to ambulation
Up until 48 hours
Length of hospital stay
Up until 7 days
- +2 more secondary outcomes
Study Arms (2)
Without placement of a catheter
EXPERIMENTALNo placement of indwelling catheter prior to Caesarean section
With placement of a catheter
ACTIVE COMPARATORPlacement of indwelling catheter prior to Caesarean section
Interventions
No placement of indwelling catheter prior to Caesarean section
Placement of indwelling catheter prior to Caesarean section
Eligibility Criteria
You may qualify if:
- Elective caesarean section.
You may not qualify if:
- Antibiotic therapy during the last week before caesarean section
- ≥ 3 prior CDs.
- Contractions or rupture of membranes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Randers Regional Hospitalcollaborator
Study Sites (1)
The Regional Hospital of Randers
Randers, 8930, Denmark
Related 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;2014(4):CD010322. doi: 10.1002/14651858.CD010322.pub2.
PMID: 24729285BACKGROUNDWeber 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. No abstract available.
PMID: 21768769BACKGROUNDGhoreishi J. Indwelling urinary catheters in cesarean delivery. Int J Gynaecol Obstet. 2003 Dec;83(3):267-70. doi: 10.1016/s0020-7292(03)00144-9.
PMID: 14643036BACKGROUNDNasr 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: 10.1038/jp.2009.4. Epub 2009 Feb 12.
PMID: 19212327BACKGROUNDSenanayake H. Elective cesarean section without urethral catheterization. J Obstet Gynaecol Res. 2005 Feb;31(1):32-7. doi: 10.1111/j.1447-0756.2005.00237.x.
PMID: 15669989BACKGROUNDOliphant 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.
PMID: 24964762BACKGROUNDPhipps 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. doi: 10.1097/01.AOG.0000149150.93552.78.
PMID: 15625157BACKGROUNDHansen BS, Soreide 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.
PMID: 21418152BACKGROUNDMulder 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 Aug 20.
PMID: 22900796BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pinar Bor, MD, Ph.D.
Aarhus University and the Region Hospital of Randers
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2018
First Posted
September 14, 2018
Study Start
June 1, 2019
Primary Completion
June 1, 2023
Study Completion
November 1, 2023
Last Updated
April 25, 2019
Record last verified: 2018-09