Foley balloon labour induction Pregnancy and Childbirth
Conditions
Interventions
All nulliparous women presenting at the induction facility of our centre for a planned induction of labour will be assessed for trial eligibility and will be counseled about this study. The patient in
Sponsors
University Malaya Medical Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Scheduled Foley balloon labour induction 2. The patient has transport available and lives within 30 minutes of the hospital 3. The patient has a functional telephone 4. Ability to communicate in English or Malay 5. Term = 37 weeks gestation 6. Singleton pregnancy 7. Nulliparous (no prior pregnancy = 22 weeks) 8. Cephalic presentation 9. Reassuring fetal heart rate monitoring 10. Intact membranes 11. Unfavourable cervix (Bishop score = 6) 12. Successful Foley balloon insertion
Exclusion criteria
Exclusion criteria: 1. Patient that contraindicated for vaginal delivery (eg: Placenta Previa, non-cephalic presentation) 2. Latex allergy 3. Fetal anomaly 4. Regular contraction of more than 2 in 10 minutes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following maternal satisfaction outcomes with the Foley balloon labour induction will be measured using an 11-point (0-10) numerical rating scale (NRS) before hospital discharge: 1. Inpatient vs. outpatient 2. By choice vs randomised 3. Inpatient by choice vs. inpatient as randomised 4. Outpatient patient by choice vs. outpatient as randomised | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal outcomes: 1. If they would recommend their intervention of inpatient or outpatient to a friend measured using a Likert scale (5-grade) response (assessed before hospital discharge) to (strongly agree to strongly disagree) before hospital discharge 2. Cervical ripening measured using the Bishop score before and after the intervention 3. Use of additional method for cervical ripening measured using data collected in medical records at the end of the study 4. Time to delivery after Foley removal/expulsion measured using data collected in medical records at the end of the study 5. Mode of delivery measured using data collected in medical records at the end of the study: 5.1. Spontaneous vaginal 5.2. Vacuum 5.3. Forceps 5.4. Caesarean section The following outcomes are measured using data collected in medical records at the end of the study: 6. Indication for operative delivery 7. Duration of oxytocin infusion 8. Blood loss during delivery 9. Third- or fourth-degree tear 10. Maternal infection 11. Use of regional analgesia in labour (epidural) 12. Length of hospital stay 13. ICU admission 14. Cardiopulmonary arrest 15. Needing hysterectomy 16. Maternal satisfaction with the Foley balloon IOL: choice vs randomised measured using an 11-point 0-10 visual numerical rating scale (NRS) Neonatal outcomes 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 ContactNorsyahirah Abd Razad
Outcome results
None listed