Induction of labour Pregnancy and Childbirth
Conditions
Interventions
Randomisation is by the opening of sealed opaque and numbered envelope with lowest available envelope assigned in strict order. Randomisation sequence will be generated using a random number generator
Sponsors
University of Malaya
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and above 2. Nulliparous women 3. Gestational age of > 37 weeks at enrollment 4. Fetus in cephalic presentation 5. Singleton fetus 6. Reassuring pre-induction fetal cardiotocography 7. Unfavourable cervix (Bishop score = 5) 8. Intact membrane 9. Able to read and understand informed consents and questionnaires
Exclusion criteria
Exclusion criteria: 1. Previous use of an induction or preinduction agent 2. Suspicion of chorioamnionitis or clinical genital tract infection 3. Allergy to latex 4. Known gross fatal anomaly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured during and at the end of the first attempt of the procedure, process will not be more than 6 minutes: 1. Time taken to successful insertion (first attempt): measurement of insertion time using a stop watch, begins when the operator’s finger or speculum entered the vagina and ended at full inflation of the catheter balloon 2. Failure of insertion (first attempt) 3. Pain score associated with the Foley catheter insertion, measured using Visual Numerical Rating Scale (VNRS) scored from 0 to 10, with higher score denoting greater pain, assessed immediately after the first insertion attempt | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal outcomes: 1. Preference of insertion method: question will be asked after intervention (insertion) 2. Use of additional method(s) for cervical ripening, obtained from patient’s medical record 3. Insertion-to-balloon expulsion or removal interval, obtained from patient’s medical record 4. Epidural analgesia usage, obtained from patient’s medical record 5. Oxytocin for labour induction or augmentation (not for third stage), obtained from patient’s medical record 6. Induction to delivery interval, obtained from patient’s medical record 7. Mode of delivery and indication for operative delivery, obtained from patient’s medical record 8. Estimated blood loss, obtained from patient’s medical record 9. Maternal satisfaction with their care from intervention to birth, assessed within 24 hours of delivery 10. Fever: single or more readings of temperature =38oC (intrapartum and day 1 postpartum), diagnosis of chorioamnionitis or endometritis, obtained from patient’s medical record Neonatal outcomes, obtained from patient’s medical record: 1. Apgar score 2. NICU admission 3. Birth weight 4. Cord pH | — |
Countries
Malaysia
Outcome results
None listed