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Self bladder emptying compared to insertion of indwelling catheter, to empty the bladder for caesarean section

Self bladder emptying compared with catheter placement for planned caesarean section: a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15821791
Enrollment
400
Registered
2021-12-31
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women undergoing planned caesarean section Pregnancy and Childbirth

Interventions

Participants will be randomised into two arms, the self-emptying of the bladder arm or the indwelling bladder catheter arm. Patients randomised to self-emptying of the bladder arm wil

Sponsors

University Malaya Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Planned caesarean section 2. Age 18 years and above 3. Gestational age (supported by dating ultrasound) =37 weeks 4. Singleton pregnancy 5. Reassuring fetal heart rate tracing

Exclusion criteria

Exclusion criteria: 1. Patients with evidence of urinary tract infection or recurrent antenatal UTI 2. Presence of large (>4 cm) ovarian or uterine masses 3. Anticipated pelvic adhesion 4. Anticipated difficult surgery or prolonged surgery time such as cases of placenta previa or accreta spectrum 5. Patients with severe pre-eclampsia or any other conditions requiring postoperative monitoring of urinary output

Design outcomes

Primary

MeasureTime frame
1. Post-partum urinary retention (PPUR) rate measured using bladder scan at hospital discharge 2. Maternal satisfaction with their allocated peri-caesarean bladder care measured using the Verbal Numeric Rating Scale (VNRS) at discharge

Secondary

MeasureTime frame
1. Intraoperative outcomes measured using case report form – data collected after caesarean section is done: 1.1. Surgical field impairment (Yes/No) 1.2. Distressed catheterization (need for catheterization during caesarean section) (Yes/No) 1.3. Operative blood loss (in milliliters) 1.4. Bladder injury (Yes/No) 1.5. Duration of surgery (in minutes) 2. Postoperative outcomes measured using case report form at 24 hours post-surgery: 2.1. Urinary tract infection with urine culture and sensitivity test at 24 hours post-surgery 2.2. Lower urinary tract symptoms (LUTS) measured with the International Prostate Symptom Score (IPSS) questionnaire upon discharge 2.3. Time to first bowel flatulence 2.4. Time to first satisfactory breastfeeding experience 2.5. Time to first satisfactory urination 2.6. Time to first satisfactory ambulation 2.7. 11-point 0-10 Verbal Numeric Rating Scale (VNRS) pain score at first post-caesarean urination 2.8. Length of hospital stay post-surgery (from operation to discharge) 2.9. 11-point 0-10 VNRS pain score upon movement at discharge

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026