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Enrolling by invitationNCT05396430Updated Apr 26, 2023

Duration of Urinary Catheter Treatment After Cesarean Delivery Under Spinal Anesthesia

An interventional study of Urinary catheter in Urinary Retention and Cesarean Section Complications, sponsored by Women's Hospital HUS. Enrolling by invitation at 1 site in Finland. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-26.

Sponsored by Women's Hospital HUS · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2023, 3 years 1 month ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
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Study 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.

Read the detailed 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.

02

Conditions studied

  • Urinary Retention
  • Cesarean Section Complications

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03

In context

Urinary Retention

235 studies on the registry are indexed under Urinary Retention; 39 are open to participants now.

This study's planned enrollment of 150 is above the median of 95 across 185 interventional studies indexed under Urinary Retention.

Browse Urinary Retention studies →

Lead sponsor

Women's Hospital HUS is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • After informed consent, signed the participation form (volunteered for the study)
  • Cesarean section
  • Spinal anesthesia

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Urinary catheter 8 hours

    The urinary cathter is to be removed at 8 hours after the end of surgery

    Device: Urinary catheter

  • Experimental
    Urinary catheter 10 hours

    The urinary cathter is to be removed at 10 hours after the end of surgery

    Device: Urinary catheter

  • Active comparator
    Urinary catheter 12 hours

    The urinary cathter is to be removed at 12 hours after the end of surgery

    Device: Urinary catheter

Interventions

  • DeviceUrinary catheter

    Duration of planned urinary cathterization following cesarean delivery

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What researchers measure

Primary outcomes

  1. Success of spontaneous voiding of bladder

    Assessed by ultrasound bladder scanner after attempted voiding of the bladder

    Time frame: 6-12 hours after removal of the urinary catheter

Secondary outcomes

  1. Amount of residual urine in the bladder

    Assessed by ultrasound

    Time frame: 6-12 hours after removal of the urinary catheter

  2. Need for standard in-house medications to help spontaneous voiding of the bladder

    Amount of medicines given

    Time frame: 6-12 hours after removal of the urinary catheter

  3. Need for re-cathterization of the bladder

    Time frame: 6-12 hours after removal of the urinary catheter

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Study locations

1 site
  • HUS/Women's hospital dept of obstetrics
    Helsinki, 00029, Finland
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05396430
Lead sponsor
Women's Hospital HUS
Responsible party
Antti Vaananen (Principal investigator, Women's Hospital HUS) — Principal investigator
First posted
May 31, 2022
Start date
Jan 1, 2023
Primary completion
Aug 31, 2023 (estimated)
Completion
Aug 31, 2023 (estimated)
Last update
Apr 26, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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