Urinary Tract Infections Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | November 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Elective caesarean section. Exclusion Criteria: 1. Antibiotic therapy during the last week before caesarean section 2. = 3 prior CDs. 3. Contractions or rupture of membranes. |
Country | Name | City | State |
---|---|---|---|
Denmark | The Regional Hospital of Randers | Randers |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Randers Regional Hospital |
Denmark,
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 Aug 20. Review. — 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: 10.1038/jp.2009.4. Epub 2009 Feb 12. — 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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The incidence of UTI later than second day postpartum | Treatment for UTI initiated by a general practitioner or hospital | 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 |
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