Användning kontra icke-användning av blåskateterisering vid elektiv kejsarsnittsförlossning
En randomiserad kontrollerad prövning av användning kontra icke-användning av blåskateterisering vid elektiv kejsarsnitt
The goal of this randomized controlled trial is to investigate the impact of routine bladder catheterization in uncomplicated cesarean sections on time to ambulation, time to discharge, urinary retention, development of urinary tract infections, prevention of bladder injury, operating time, and patient satisfaction.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This would be a randomized controlled trial conducted on the labour and delivery and post-partum unit at a large academic site (Foothills Medical Centre) in Calgary, Alberta. Study recruitment of patients awaiting delivery via CS would occur either in participating prenatal clinics in Calgary or in obstetrical triage by a trained nurse research assistant. Participants would be randomized into either a catheterized or non-catheterized group prior to their scheduled elective CS. Allocation concealment will be ensured by using either a central computer generator for randomization if funding permits, otherwise sealed, opaque, and sequenced envelopes will be used. Since there may be potential differences in patients with increasing parity, randomization will be stratified by parity and blocked to prevent imbalance in treatment groups.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Alberta
-
Calgary, Alberta, Kanada, T2N 2T9
- University of Calgary
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion criteria:
- women who are 18 years of age or older with a singleton pregnancy presenting for an elective primary or repeat CS.
Exclusion criteria:
- diagnosis of abnormal placentation including placenta previa, vasa previa, or suspected invasive disease
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Bladder catheterization
Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post Cesarean section. |
Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post cesarean section. |
|
Inget ingripande: Non-use of bladder catheterization
Participants in the non-catheterized group would be encouraged to empty their bladders just prior to transfer to the operating room where they will undergo surgery without an indwelling catheter. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to ambulation
Tidsram: Prior to discharge, assessed up to 3 days postpartum
|
Time to ambulation will be collected via a form that will be distributed by the postpartum nursing team. |
Prior to discharge, assessed up to 3 days postpartum
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of urinary retention
Tidsram: Prior to discharge, assessed up to 3 days postpartum
|
Urinary retention will be defined based on a patient's inability to spontaneously void requiring either in-and-out catheterization or placement of an indwelling catheter during the post operative course |
Prior to discharge, assessed up to 3 days postpartum
|
|
Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum
Tidsram: first 4 weeks postpartum
|
Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum |
first 4 weeks postpartum
|
|
Incidence of bladder injury in surgery
Tidsram: During surgery
|
Incidence of bladder injury in surgery will be collected via an electronic post-operative questionnaire filled out by the operating surgeon. |
During surgery
|
|
Operating time
Tidsram: During surgery
|
Operating time will be collected via an electronic post-operative questionnaire filled out by the operating surgeon. |
During surgery
|
|
Patient satisfaction as measured by the Maternal Satisfaction for Cesarean Section questionnaire (MSCS)
Tidsram: At discharge, assessed up to 3 days postpartum
|
Patients will be asked to complete the Maternal Satisfaction for Cesarean Section questionnaire at discharge. The minimum and maximum values are 7 and 154 and higher scores mean a better outcome. |
At discharge, assessed up to 3 days postpartum
|
|
Time to discharge
Tidsram: At discharge, assessed up to 3 days postpartum
|
Time to discharge; date and time of discharge will be collected during chart review |
At discharge, assessed up to 3 days postpartum
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Stephen L. Wood, MD, MSc, University of Calgary
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- REB24-0044
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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