Induction of labour after one previous caesarean section Pregnancy and Childbirth
Conditions
Interventions
Patients are screened on their admission for their planned labour induction for eligibility to participate in the trial. They will be given written and verbal information about the trial. All particip
Sponsors
University Malaya Medical Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Scheduled labour induction 2. One previous lower segment caesarean 3. Singleton fetus (one baby) 4. Term: = 37 weeks of pregnancy 5. 18 years and above 6. Cephalic presentation (head first) 7. Reassuring fetal heart rate tracing (baby in good condition) 8. Unripe cervix (Modified Bishop Score = 6) 9. Absence of significant painful contraction (= 2 in 10 minutes) 10. Intact membranes 11. Successful Foley balloon insertion for IOL
Exclusion criteria
Exclusion criteria: 1. Latex Allergy 2. Estimated fetal weight = 2kg or = 4kg before induction and confirmed by ultrasound 3. Known major fetal malformations 4. Contraindications for vaginal delivery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal satisfaction with the birth experience will be assessed using the following measures before hospital discharge: 1. 12 vs 24 hours duration of Foley balloon placement using a 0-10 numerical rating scale (NRS) 2. Choice vs Randomized using a 0-10 NRS 3. 12-hour duration by choice vs 12-hour duration as randomized using a 0-10 NRS 4. 24-hour duration by choice vs 24-hour duration as randomized using a 0-10 NRS | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal Outcomes: 1. Maternal satisfaction with the Foley placement regimen will be assessed using the following measures before hospital discharge: 1.1. 12 vs 24 hours duration of Foley balloon placement using a 0-10 numerical rating scale (NRS) 1.2. Choice vs Randomized using a 0-10 NRS 1.3. 12-hour duration by choice vs 12-hour duration as randomized using a 0-10 NRS 1.4. 24-hour duration by choice vs 24-hour duration as randomized using a 0-10 NRS 2. Response to whether they will recommend their intervention of 12 hours or 24 hours for Foley catheter placement for IOL to a friend measured using a Likert scale (5-grade; strongly agree to strongly disagree) before hospital discharge The following measures are assessed using data collected from medical records at the end of the study: 3. Change in bishop score after intervention 4. Use of additional method for cervical ripening 5. Time to delivery after Foley insertion 6. Time to delivery after Foley removal/ expulsion 7. Mode of delivery 8. Indication for cesarean section 9. Duration of oxytocin infusion 10. Blood loss during delivery 11. Third- or fourth-degree tear 12. Maternal infection (fever = 380C) 13. Use of regional analgesia in labour (epidural) 14. Length of hospital stay 15. ICU admission 16. Needing hysterectomy The following neonatal outcome measures are assessed using data collected from medical records, unless stated, at the end of the study: 1. Newborn health measured using Apgar scoring at 1 and 5 minutes 2. NICU admission 3. Cord artery pH 4. Neonatal sepsis 5. Birth weight 6. Birth trauma 7. Hypoxic ischaemic encephalopathy/need for therapeutic hypothermia | — |
Countries
Malaysia
Contacts
Public ContactAimi Dayana Binti Harun
Outcome results
None listed