What are the efficacy and safety outcomes on the mother and fetus, when a transcervical Foley catheter is used for 48 hours in the induction of labor, as an outpatient procedure compared to an inpatient procedure?

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

•Women with live singleton pregnancies with a cephalic presentation •Women with >37 weeks +0 days to 42 weeks +0 days gestation, with intact membranes requiring IOL •Women living within 20km or less (40-minute drive or less) from the hospital, having a telephone, and someone to provide transport to the hospital in an emergency

• Women with high-risk pregnancies (heart disease, hypertension, hyper-glycaemia on metformin or insulin therapy, fetal growth restriction) • Less than 18 years of age • Major congenital anomaly as per routine anomaly scan • Previous caesarean delivery • Modified Bishop Score (MBS) > 6 • Evidence of regular uterine contractions • Known hypersensitivity for any of the products for induction/ latex • Any contraindications to vaginal birth, i.e. Placenta praevia • Evidence of any vaginal or cervical infection