Comparing two different interventions after balloon catheter induction of labour in women who have not delivered a child before

INTERVENTION: All nulliparous women planned for induction of labour by the care provider will be assessed for eligibility and will be counselled regarding this study in the clinic and antenatal ward setting. If the women agree to participate in the study, informed consent will be obtained, and the patient information sheet will be handed to them. On the scheduled date of induction, consented women will present themselves to the antenatal ward for an initial assessment including Bishop scoring and pre‐induction fetal cardiotocography (CTG). If these patients Bishop score and or CTG are not met within the inclusion criteria, they are excluded from the study. Women will be positioned in the dorsal position. A Foley catheter size 16F is then introduced through the external os using either digital or speculum method (at the discretion of introducer). Once the tip of the catheter has passed the internal os by 4 to 5 cm, the balloon will be inflated with 60 ml of water and retracted so the balloon rests on the internal cervical os. The other end of the Foley catheter will be taped without tension to the medial aspect of the women’s thigh. Fetal monitoring will be performed immediately after the inflation of the balloon catheter. Once the catheter is in‐situ and the post Foley catheter insertion CTG is normal, only then randomisation will be carried out. Randomisation is done by opening a sealed opaque and numbered envelope with the lowest available envelope assigned in strict order. Randomisation will be done using a random number generator at Random.org in random blocks of 4 or 8 sequence, generated by an investigator who is not involved in recruitment. Blinding is not possible due to the nature of the intervention. CONDITION: Outpatient Foley catheter induction of labour in nulliparous women ; Pregnancy and Childbirth PRIMARY OUTCOME: ; 1. Maternal satisfaction evaluated using a visual numerical scale scored 0‐10, assessed within 24 hours of delivery; 2. Duration of active labour, defined as amniotomy and oxytocin to delivery interval, measured in hr:min; obtained from patient's medical records at birth; INCLUSION CRITERIA: 1. Nulliparous 2. Age 18 years and above 3. Gestational age of = 37weeks at enrolment 4. Scheduled induction of labour 5. Viable pregnancy 6. Cephalic presentation 7. Singleton pregnancy 8. Unfavourable cervix (Bishop score = 5) 9. Absence of significant contraction = 2 in 10 minutes 10. Intact membranes 11. Reassuring pre induction fetal cardiotocography (CTG) 12. Patient has motor vehicle 13. Patient stays about 30 minutes distance from University Malaya Medical Centre SECONDARY OUTCOME: ; Maternal outcome measures:; 1. Induction to delivery interval (duration measured in hr:min), obtained from patient's medical records at birth; 2. Mechanism of membrane rupture (amniotomy or spontaneous rupture of membrane), obtained from patient's medical records at birth; 3. Oxytocin augmentation (duration measured in hr:min), obtained from patient's medical records at birth; 4. Use of additional method(s) of cervical ripening, obtained from patient's medical records at birth; 5. Use of regional analgesia in labour, obtained from patient's medical records at birth; 6. Mode of delivery, obtained from patient's medical records at birth; 7. Estimated blood loss, obtained from patient's medical records at birth; 8. Fever; one or more readings of temperature = 38°C, diagnosis of chorioamnionitis or endometritis, obtained from patient's medical records intrapartum and day 1 postpartum; 9. Total duration of hospital stay, obtained from patient's medical records on discharge; 10. Date and time of catheter removal/dislodged, obtained from patient's medical records upon admission to hospital; ; Neonatal outcome measures:; 1. Apgar score at 1 and 5 minutes measured using the Apgar score chart at 1 and 5 minutes of birth; 2. Arterial cord pH: blood drawn into a heparinized syringe taken from the umbilical artery of the umbilical cord after delivery of the baby, measured using a blood gas machine located in the labour ward at time of birth; 3. Birth weight measured using a calibrated digital weighing scale located in the labour ward nursery at birth; 4. Neonatal admission, taken from the medical records of the baby at birth or before mother's date of hospital discharge;