Date

2021-11-13

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

Study settings: Six Teaching Hospitals in Sri Lanka- Teaching Hospital, Mahamodara, Galle, North Colombo Teaching Hospital, Teaching Hospital, Anuradhapura, Teaching Hospital, Batticaloa, Castle Street Hospital for Women, Colombo and De Soysa Hospital for Women, Colombo. Randomization a. Method of randomization into study arms - Variable block randomisation b. Unit of randomization- Each eligible woman for induction of labour. c. Method of sequence generation- Randomisation sequence will be prepared by an independent statistician and maintained centrally by the central coordinating center (central telephone randomisation by the research nurse/doctor from De Soysa Hospital for Women, Colombo). Allocation ratio - 1:1. d. Method of allocation concealment- Central telephone randomisation. Intervention Eligible women will be identified at their last antenatal clinic visit and low-risk women at 40 weeks +3 days of gestation and/or any other low-risk women requiring induction of labour after 37 weeks of gestation will be admitted to the hospital. After admission, patient information sheets will be provided and informed written consent will be taken from all eligible women. Thereafter, a vaginal examination will take place. For women who have a Bishop score <6, a sterile vaginal speculum examination will be performed in the dorsal position by a postgraduate resident or a senior medical officer (at least one year experience) and a 16Fr standard latex transcervical Foley catheter will be inserted under aseptic conditions after cleaning with povidone-iodine. The catheter will be inflated with 60mL sterile water. The urinary channel of the Foley catheter will be closed off with a sterile cap. The catheter will be taped into the inner aspect of the thigh to allow her to move comfortably and after applying gentle traction against the internal cervical os. After catheter insertion, they will be observed for 30-minutes of bed rest, while fetal condition and uterine activity are monitored. A post-procedure 20-minute cardiotocogram will be offered one hour after insertion and if the cardiotocogram is normal, women will be randomised into two arms; home and hospital settings. Control Induction of labour with Foley catheter for 48 hours while as an inpatient. This is the accepted standard method for induction of labour with mechanical methods. Blinding - No blinding

Next Version

1. Study settings: Six Teaching Hospitals in Sri Lanka- Teaching Hospital, Mahamodara, Galle, North Colombo Teaching Hospital, Teaching Hospital, Anuradhapura, Teaching Hospital, Batticaloa, Castle Street Hospital for Women, Colombo and De Soysa Hospital for Women, Colombo. 2. Randomization a. Method of randomization into study arms - Variable block randomisation b. Unit of randomization- Each eligible woman for induction of labour. c. Method of sequence generation- Randomisation sequence will be prepared by an independent statistician and maintained centrally by the central coordinating center (central telephone randomisation by the research nurse/doctor from De Soysa Hospital for Women, Colombo). Allocation ratio - 1:1. d. Method of allocation concealment- Central telephone randomisation. 3. Intervention Eligible women will be identified at their last antenatal clinic visit and low-risk women at 40 weeks +3 days of gestation and/or any other low-risk women requiring induction of labour after 37 weeks of gestation will be admitted to the hospital. After admission, patient information sheets will be provided and informed written consent will be taken from all eligible women. Thereafter, a vaginal examination will take place. For women who have a Bishop score <6, a sterile vaginal speculum examination will be performed in the dorsal position by a postgraduate resident or a senior medical officer (at least one year experience) and a 16Fr standard latex transcervical Foley catheter will be inserted under aseptic conditions after cleaning with povidone-iodine. The catheter will be inflated with 40mL sterile water. The urinary channel of the Foley catheter will be closed off with a sterile cap. The catheter will be taped into the inner aspect of the thigh to allow her to move comfortably and after applying gentle traction against the internal cervical os. After catheter insertion, they will be observed for 30-minutes of bed rest, while fetal condition and uterine activity are monitored. A post-procedure 20-minute cardiotocogram will be offered one hour after insertion and if the cardiotocogram is normal, women will be randomised into two arms; home and hospital settings. 4. Control Induction of labour with Foley catheter for 24 hours while as an inpatien. This is the accepted standard method for induction of labour with mechanical methods. 5. Blinding - No blinding