Duration of Urinary Catheter Treatment After Cesarean Delivery Under Spinal Anesthesia

Cesarean Section Complications Clinical Trial

Official title:

Early Recovery After Cesarean Delivery: Duration of Urinary Catheter Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05396430
• Other study ID #: Tutkimussuunnitelma25032022
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: April 2023
• Source: Women's Hospital HUS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study a total of 150 parturients undergoing cesarean delivery under spinal anesthesia will be randomized to have their urinary catheters kept in place for 8, 10 or 12 hours. The incidence of urinary retention and interventions needed for any potential urinary retention will be assessed.

Description:

In this study a total of 150 parturients undergoing cesarean delivery under spinal anesthesia will be randomized to have their urinary catheters kept in place for 8, 10 or 12 hours. The incidence of urinary retention and interventions needed for any potential urinary retention will be assessed.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• After informed consent, signed the participation form (volunteered for the study)

• Cesarean section

• Spinal anesthesia

Exclusion Criteria:

• Prior neuraxial analgesia (epidural or spinal) for attempted labour

Related Conditions & MeSH terms

• Cesarean Section Complications
• Urinary Retention

Intervention

Device:
• Urinary catheter
Duration of planned urinary cathterization following cesarean delivery

Locations

Country	Name	City	State
Finland	HUS/Women's hospital dept of obstetrics	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital HUS

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of spontaneous voiding of bladder	Assessed by ultrasound bladder scanner after attempted voiding of the bladder	6-12 hours after removal of the urinary catheter
Secondary	Amount of residual urine in the bladder	Assessed by ultrasound	6-12 hours after removal of the urinary catheter
Secondary	Need for standard in-house medications to help spontaneous voiding of the bladder	Amount of medicines given	6-12 hours after removal of the urinary catheter
Secondary	Need for re-cathterization of the bladder		6-12 hours after removal of the urinary catheter