Induction of labour in women with nonscarred uterus using balloon catheter: Randomised controlled trial

Induction of labour is a common obstetric procedure. At present, different methods are used for induction of labour in women. One of these methods is Foley catheter, which is a low cost method that can induce labour with less risk to the fetus. This is one of the first studies in the Middle East aiming to study efficacy and safety of Foley catheter induction in nonscarred uterus of term pregnant women in comparison to prostaglandin vaginal tablet. This trial will be a single centre, open-label, randomised controlled trial. It will be performed in Madinah Maternity and Children Hospital (MMCH). Randomisation will be conducted using simple alternative patient randomization. First patient will receive transcervical Foley catheter induction, while the next will receive 3mg prostaglandin vaginal tablets according to hospital protocol. There will be no blinding of patients and caregivers, as this is not possible with these two treatment methods. Outcomes included induction to delivery interval, mode of birth, maternal morbidity, APGAR score less than 7 at 5minutes, and fetal admission to NICU. Sample size of 500 participants planned over the study period of 12 months. Intention to treat analysis will be used.