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
|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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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
- Any need for catheterization due to postoperative urinary retention [ Time Frame: 24 hours ]Any need for catheterization due to postoperative urinary retention
- Postpartum blood loss >1000 mL. [ Time Frame: 4 hours ]Postpartum blood loss >1000 mL.
- Time to ambulation [ Time Frame: Up until 48 hours ]From time of birth and until standing or walking
- Length of hospital stay [ Time Frame: Up until 7 days ]From time of birth and until discharge.
- Intraoperative laceration of the bladder [ Time Frame: 7 days ]Laceration of bladder during surgery
- The incidence of preoperative bacteria in urineculture [ Time Frame: 1 day ]Positive urine culture preoperatively
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
|Contact: Helle Folge Bungum, MDfirstname.lastname@example.org|
|Contact: Pinar Bor, MD, Ph.D.||+45 7842 email@example.com|
|The Region Hospital of Randers||Recruiting|
|Randers, Denmark, 8930|
|Contact: Helle Folge Bungum, MD +4525794505 firstname.lastname@example.org|
|Contact: Pinar Bor, MD, Ph.D. +45 7842 1131 email@example.com|
|Study Chair:||Pinar Bor, MD, Ph.D.||Aarhus University and the Region Hospital of Randers|