Continuous compared to intermittent bladder catheterisation for epidural analgesia in labour

Category Primary study
Registry of TrialsISRCTN registry
Year 2024
INTERVENTION: After the successful commencement of epidural analgesia 1. For participants randomised to continuous bladder catheterisation, the 16F Foley catheter will be inserted under a standard aseptic technique. The balloon will be inflated to 10 ml. The catheter will be left in place until after delivery (to cover perineal repair). OR 2. For participants randomised to intermittent bladder catheterisation, in and out bladder catheterisation will be performed under a standard aseptic technique every 4 hours (or earlier if the bladder is clinically distended or there is the urge to void). Method Women who requested epidural analgesia in labor will be assessed for eligibility. Potentially eligible patients will be given the ‘Patient Information Sheet’, encouraged to ask about the study and have their queries answered. After the successful epidural, written informed consent patient will be obtained, and randomisation performed without delay to receive intermittent (IC) or continuous indwelling bladder catheterization (CC). Randomisation will be by the opening of an opaque sealed numbered envelope containing the allocated intervention. The randomisation sequence will be generated using an online generator in blocks of 4 or 8 by an investigator not involved in trial recruitment. The lowest numbered envelope will be opened for the newest recruit. Standard labour care will be provided to all participants. CONDITION: Epidural analgesia in labour ; Pregnancy and Childbirth PRIMARY OUTCOME: The following primary outcome variables will be measured using data collected in medical notes during the delivery:; 1. Delivery blood loss (= 500 ml) ; 2. Cesarean delivery SECONDARY OUTCOME: The following secondary outcome variables will be measured using data collected in medical notes during the delivery:; 1. Epidural insertion to second stage interval; 2. Epidural insertion to delivery interval; 3. Epidural insertion to removal interval; 4. Epidural insertion to discharge interval; 5. Mode of delivery (indication for caesarean); 6. Perineal condition; 7. Estimated delivery blood loss; 8. Birth weight; 9. Apgar score at 1 and 5 minutes; 10. Umbilical cord artery blood pH; 11. Neonatal intensive care admission (and indication); 12. Satisfaction with allocated bladder catheterisation regimen 0‐10 NRS INCLUSION CRITERIA: 1. Received intrapartum epidural analgesia 2. 1st stage of labour (at least 3 cm dilated and 2 contractions every 10 minutes) 3. = 37 weeks gestation 4. Age =18 years old 5. Singleton fetus 6. Cephalic presentation 7. Reassuring fetal heart rate tracing
Epistemonikos ID: 1d5c0641c40c3a9a799f0117e6c9e98384a364cf
First added on: Aug 28, 2024