Induction of labour Pregnancy and Childbirth
Conditions
Interventions
Recruitment:
Patients admitted for their planned labour induction will be screened for eligibility. Potentially eligible patients will be approached, provided with the patient information sheet, and v
Sponsors
University Malaya Medical Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women (at least one vaginal delivery =24 weeks) 2. Age =18 years 3. Gestational age of =37 weeks 4. Singleton pregnancy 5. Cephalic presentation 6. Intact membrane 7. Reassuring fetal heart tracing 8. Absence of significant contraction =2 in 10 minutes 9. Successful Foley insertion for IOL
Exclusion criteria
Exclusion criteria: 1. History of caesarean delivery or hysterotomy/uterine perforation/previous myomectomy 2. Latex allergy 3. Estimated fetal weight less than 2 kg or >4 kg 4. Fetus with anomaly 5. Contraindication for vaginal delivery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal satisfaction with their labour induction scored with the 11-point 0-10 visual numerical rating scale in the following settings: 1. At home (for up to 24 hours if no interim events, before readmission for labour and delivery) compared to in hospital (until after delivery) 2. Whereby the labour induction location is chosen by the women compared to randomly assigned 3. At home by women’s choice compared to at home as randomly assigned 4. In-hospital by women’s choice compared to in-hospital as randomly assigned Scored with the 0-10 numerical rating scale (NRS) within 24 hours of delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| All retrieved from participants’ electronic medical records after their hospital discharge: Based on the core outcome set for trials on induction of labour (CROWN): Maternal outcomes: 1. Change in bishop score after intervention 2. Use of additional cervical ripening 3. Time to delivery after Foley removal/expulsion 4. Mode of delivery: 4.1. Spontaneous vaginal 4.2. Vacuum 4.3. Forceps 4.4. Caesarean section 5. Indication for operative delivery 6. Duration of oxytocin infusion 7. Blood loss during delivery 8. Third-or fourth-degree tear 9. Maternal infection (temperature =38oC from IOL to discharge) 10. Regional analgesia in labour (epidural) 11. Length of hospital stay 12. ICU admission (and indication) 13. Cardiorespiratory arrest 14. Needing hysterectomy Neonatal outcomes: 15. Apgar score at 1 and 5 minutes 16. NICU admission (and indication) 17. Cord artery pH and base excess 18. Neonatal sepsis 19. Birth weight 20. Birth trauma 21. Hypoxic ischaemic encephalopathy/need for therapeutic hypothermia 22. Before their discharge, participants will be asked to provide a 5-grade Likert scale response on if they will recommend their their Foley catheter IOL to a friend | — |
Countries
Malaysia
Contacts
Public ContactKauthar Binti Zahir
Outcome results
None listed