NCT03479931

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

February 14, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 4, 2021

Status Verified

September 1, 2017

Enrollment Period

4 months

First QC Date

March 12, 2018

Last Update Submit

October 27, 2021

Conditions

Cesarean Section; InfectionCatheter-Related Infections

Outcome Measures

Primary Outcomes (1)

  • 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 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

EXPERIMENTAL

Without preoperatively placement of an indwelling catheter during Caesarean section

Procedure: Without placement of a catheter

With placement of a catheter

ACTIVE COMPARATOR

Normal pre-operative routines with placement of an indwelling catheter during Caesarean section

Procedure: With placement of a catheter

Interventions

Without placement of a catheterPROCEDURE

Elective cesarean section without preoperative placement of a urinary catheter.

Without placement of a catheter
With placement of a catheterPROCEDURE

Elective cesarean section with preoperative placement of a urinary catheter.

With placement of a catheter

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Region Hospital of Randers

Randers, 8930, Denmark

Location

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: 24729285RESULT

  • 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. No abstract available.

    PMID: 21768769RESULT

  • Ghoreishi 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: 14643036RESULT

  • 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.

    PMID: 19212327RESULT

  • Senanayake 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: 15669989RESULT

  • 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.

    PMID: 24964762RESULT

  • 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. doi: 10.1097/01.AOG.0000149150.93552.78.

    PMID: 15625157RESULT

  • Hansen 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: 21418152RESULT

  • 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.

    PMID: 22900796RESULT

MeSH Terms

Conditions

InfectionsCatheter-Related Infections

Study Officials

  • Pinar Bor, MD, Ph.D.

    Aarhus University and the Region Hospital of Randers

    STUDY CHAIR

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

March 12, 2018

First Posted

March 27, 2018

Study Start

February 14, 2018

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

November 4, 2021

Record last verified: 2017-09

Locations

DK(1)