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Trial record 68 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

Caesarean Delivery With or Without an Indwelling Bladder Catheter

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ClinicalTrials.gov Identifier: NCT03672214
Recruitment Status : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : September 14, 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
Urinary Tract Infections Cesarean Section; Infection Procedure: Without placement of indwelling catheter Procedure: With placement of indwelling 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
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Without placement of a catheter
No placement of indwelling catheter prior to Caesarean section
Procedure: Without placement of indwelling catheter
No placement of indwelling catheter prior to Caesarean section

Active Comparator: With placement of a catheter
Placement of indwelling catheter prior to Caesarean section
Procedure: With placement of indwelling catheter
Placement of indwelling catheter prior to Caesarean section




Primary Outcome Measures :
  1. The incidence of urinary tract infection (UTI). [ Time Frame: 3 days ]
    Urine culture (second day post partum) yielding ≥ 10*5 CFU/ml (of one type of bacteria).


Secondary Outcome Measures :
  1. The incidence of UTI later than second day postpartum [ Time Frame: 30 days ]
    Treatment for UTI initiated by a general practitioner or hospital

  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
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03672214


Contacts
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Contact: Helle F 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 Regional Hospital of Randers
Randers, Denmark, 8930
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:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03672214     History of Changes
Other Study ID Numbers: 1-10-72-113-17_2
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Urinary Tract Infections
Urologic Diseases