Duration of Urinary Catheter Treatment After Cesarean Delivery Under Spinal Anesthesia

NCT ID: NCT05396430

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Retention Cesarean Section Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The parturients are randomized into 3 different treatment arms with different duration of planned urinary catheter treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Masking is not applicable, duration of urinary catheter treatment is decided at the time of surgery.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Urinary catheter 8 hours

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

Group Type EXPERIMENTAL

Urinary catheter

Intervention Type DEVICE

Duration of planned urinary cathterization following cesarean delivery

Urinary catheter 10 hours

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

Group Type EXPERIMENTAL

Urinary catheter

Intervention Type DEVICE

Duration of planned urinary cathterization following cesarean delivery

Urinary catheter 12 hours

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

Group Type ACTIVE_COMPARATOR

Urinary catheter

Intervention Type DEVICE

Duration of planned urinary cathterization following cesarean delivery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Urinary catheter

Duration of planned urinary cathterization following cesarean delivery

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Women's Hospital HUS

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Antti Vaananen

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HUS/Women's hospital dept of obstetrics

Helsinki, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Tutkimussuunnitelma25032022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.