Induction of labour Pregnancy and Childbirth
Conditions
Interventions
This is a planned randomised control trial. All eligible women will be approached, provided with the Patient Information Sheet, verbally counseled, and their queries answered by the care provider for
including their personal characteristics, obstetric assessment, and fetal wellbeing (using a non-stress cardiotocogram) assessment.
Participants will be positioned in the dorsal position. Bishop scor
Sponsors
University Malaya Medical Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Nulliparous 2. Aged =18 years 3. Gestational age =37 weeks 4. Singleton pregnancy 5. Cephalic presentation 6. Intact membrane 7. Reassuring fetal heart tracing 8. Absence of significant contraction =2 in 10 min 9. Successful Foley catheter insertion 10. Bishop score =5
Exclusion criteria
Exclusion criteria: 1. History of Caesarean delivery or hysterotomy/uterine perforation/previous myomectomy 2. Latex allergy 3. Estimated fetal weight 4 kg 4. Placenta previa including minor previa 5. Major fetal malformations 6. Contraindication for vaginal delivery 7. Suspected COVID-19 infection or COVID-19 positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to delivery after induction measured from the time of induction and the time of delivery recorded in the Case Report Form at induction of labour and delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal outcomes: 1. Estimate of the readiness of the cervix for labor measured using Bishop score calculated before insertion of the catheter and after removal of the catheter 2. Use of additional method for cervical ripening measured from the Case Report Form after removal of the catheter 3. Time to delivery after Foley removal measured from the time of catheter removal and the time of delivery recorded in the Case Report Form at removal of the catheter and delivery 4. Mode of delivery measured from the Case Report Form at delivery 5. Indication for caesarean section measured from the Case Report Form at delivery 6. Duration of oxytocin infusion measured from the Case Report Form after oxytocin infusion 7. Maternal satisfaction-based allocation to intervention until birth measured using 11-point Verbal Numerical Rating Score (VNRS) at the end of the study 8. Blood loss during delivery measured from the Case Report Form at delivery 9. Third -or fourth-degree tear measured from the Case Report Form at delivery 10. Maternal infection measured from data in the Case Report Form collected throughout the study 11. Use of regional analgesia in labour measured from the Case Report Form at delivery 12. Length of hospital stay measured from the time of admission and the time of discharge recorded in the Case Report Form between hospital admission and discharge 13. Need for ICU admission measured from data in the Case Report Form collected throughout the study Neonatal outcomes: 1. Neonatal health measured using Apgar score at 1 and 5 min after delivery 2. Need for NICU admission measured from the Case Report Form collected throughout the study 3. Fetal metabolic condition measured using Cord pH at delivery 4. Neonatal sepsis measured from the Case Report Form collected after delivery 5. Birth weight measured from the Case Report Form collected after delivery 6. Birth trauma measured from the Case Report Form collected after delivery 7. Hypoxic ischaemic encephalopathy/ne | — |
Countries
Malaysia
Outcome results
None listed