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

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ClinicalTrials.gov Identifier: NCT03479931
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Randers Regional Hospital
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Cesarean Section; Infection Catheter-Related Infections Procedure: Without placement of a catheter Procedure: With placement of a catheter Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Caesarean Delivery With or Without an Indwelling Bladder Catheter.
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : February 14, 2022
Estimated Study Completion Date : February 14, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Without placement of a catheter
Without preoperatively placement of an indwelling catheter during Caesarean section
Procedure: Without placement of a catheter
Elective cesarean section without preoperative placement of a urinary catheter.

Active Comparator: With placement of a catheter
Normal pre-operative routines with placement of an indwelling catheter during Caesarean section
Procedure: With placement of a catheter
Elective cesarean section with preoperative placement of a urinary catheter.




Primary Outcome Measures :
  1. The incidence of urinary tract infection (UTI). [ Time Frame: 3 days ]
    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.


Secondary Outcome Measures :
  1. The incidence of UTI later than second day postpartum [ Time Frame: 30 days ]
    UTI verified by a positive culture and/or treatment for UTI initiated by a general practitioner

  2. Any need for catheterization due to postoperative urinary retention [ Time Frame: 24 hours ]
    Any need for catheterization due to postoperative urinary retention

  3. Postpartum blood loss >1000 mL. [ Time Frame: 4 hours ]
    Postpartum blood loss >1000 mL.

  4. Time to ambulation [ Time Frame: Up until 48 hours ]
    From time of birth and until standing or walking

  5. Length of hospital stay [ Time Frame: Up until 7 days ]
    From time of birth and until discharge.

  6. Intraoperative laceration of the bladder [ Time Frame: 7 days ]
    Laceration of bladder during surgery

  7. The incidence of preoperative bacteria in urineculture [ Time Frame: 1 day ]
    Positive urine culture preoperatively



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479931


Contacts
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Contact: Helle Folge Bungum, MD +4525794505 hellbung@rm.dk
Contact: Pinar Bor, MD, Ph.D. +45 7842 1131 isipinbo@rm.dk

Locations
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Denmark
The Region Hospital of Randers Recruiting
Randers, Denmark, 8930
Contact: Helle Folge Bungum, MD    +4525794505    hellbung@rm.dk   
Contact: Pinar Bor, MD, Ph.D.    +45 7842 1131    isipinbo@rm.dk   
Sponsors and Collaborators
University of Aarhus
Randers Regional Hospital
Investigators
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Study Chair: Pinar Bor, MD, Ph.D. Aarhus University and the Region Hospital of Randers

Publications of Results:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03479931     History of Changes
Other Study ID Numbers: 1-10-72-113-17
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not yet discussed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Catheter-Related Infections