Tugging the foley's catheter every three hours in the labor induction of women with a previous caesarean section

Category Primary study
Registry of TrialsISRCTN registry
Year 2023
INTERVENTION: Participants will be randomly allocated by sealed envelope to receive either: 1. During Foley balloon cervical ripening, the catheter will be tugged intermittently, every three hours to check for dislodgement (indicating a ripened cervix) following which the balloon will be retrieved and amniotomy and titrated oxytocin infusion can commence expediting labour and delivery OR: 2. Standard care during Foley balloon cervical ripening whereby the Foley balloon will be passively left in place (no tugging) to await spontaneous expulsion. Following spontaneous expulsion with the cervi Xripened, amniotomy and titrated oxytocin infusion can commence expediting labour and delivery After 12 hours if the Foley has not been retrieved through tugging or spontaneously expelled, the balloon will be deflated and the catheter removed. The cervi Xwill then be assessed to decide further management by the care provider guided by institutional care protocols and practices. Standard care during labour induction, labour, delivery and after delivery will be provided to all participants CONDITION: Women who had a prior caesarean delivery undergoing cervical ripening in labour induction ; Pregnancy and Childbirth PRIMARY OUTCOME: ; 1. Induction (Foley insertion) to delivery interval; 2. Maternal satisfaction with birth experience after labor induction by 11‐point 0‐10 Visual Numerical Rating Scale.; INCLUSION CRITERIA: 1. One previous uncomplicated transverse lower segment cesarean section 2. Age = 18 years 3. Gestational age of = 37 weeks 4. Singleton pregnancy 5. Cephalic presentation 6. Intact membrane 7. Reassuring fetal heart rate tracing 8. Absence of significant contraction = 2 in 10 minutes 9. Successful Foley insertion for induction of labour SECONDARY OUTCOME: ; Maternal outcomes; 1. Change in bishop score after intervention (obtained from hospital record after hospital discharge); 2. Use of additional method for cervical ripening (obtained from hospital record after hospital discharge); 3. Time to delivery after Foley removal/expulsion (obtained from hospital record after hospital discharge); 4. Mode of delivery (obtained from hospital record after hospital discharge); 4.1. spontaneous vaginal; 4.2. vacuum; 4.3. forceps; 4.4. caesarean section; 5. Indication for operative delivery (obtained from hospital record after hospital discharge); 6. Duration of oxytocin infusion (obtained from hospital record after hospital discharge); 7. Blood loss during delivery (obtained from hospital record after hospital discharge); 8. Third‐or fourth‐degree tear (obtained from hospital record after hospital discharge); 9. Maternal infection (obtained from hospital record after hospital discharge); 10. Use of regional analgesia in labor (epidural) (obtained from hospital record after hospital discharge); 11. Length of hospital stay (obtained from hospital record after hospital discharge); 12. ICU admission (obtained from hospital record after hospital discharge); 13. Cardiorespiratory arrest (obtained from hospital record after hospital discharge); 14. Hysterectomy (obtained from hospital record after hospital discharge); 15. Maternal satisfaction with the allocated intervention; ; Neonatal outcomes (obtained from hospital record after hospital discharge); 16. Apgar score at 1 and 5 minutes (obtained from hospital record after hospital discharge); 17. NICU admission (obtained from hospital record after hospital discharge); 18. Cord artery pH (obtained from hospital record after hospital discharge); 19. Neonatal sepsis (obtained from hospital record after hospital discharge); 20. Birth weight (obtained from hospital record after hospital discharge); 21. Birth trauma (obtained from hospital record after hospital discharge); 22. Hypoxic ischaemic encephalopathy/need for therapeutic hypothermia (obtained from hospital record after hospital discharge);
Epistemonikos ID: beb2e723fc046da0dec07c437818471058333c4f
First added on: Mar 29, 2023