Secondary outcomes
| Safety outcomes |
Baby
Any neonatal unit (NNU) admission (any level of care) Neonatal intensive care unit (NICU) admission Duration of NNU stay Duration of NICU stay Apgarscore <7 at 5 min Apgar score <4 at 5 min Arterial cord blood pH <7.1 Arterial cord base excess >12 mmol/L Neonatal seizures Hypoxic ischaemic encephalopathy (as recorded by care givers) Level 2 or level 3 hypoxic ischaemic encephalopathy (as recorded by care givers) Meconium aspiration syndrome Mechanical ventilation Intracranial haemorrhage Stillbirth after admission/first attendance for induction of labour (excluding deaths from congenital anomalies) Early neonatal death up to 7 days after birth (day 0–6; excluding deaths from congenital anomalies) Treatment for neonatal sepsis (defined as positive blood, cerebral spinal fluid, or urine culture or cardiovascular collapse or X-ray confirming infection) (exploratory outcome) Treatment in NNU for neonatal infection (defined as antibiotic treatment and temperature ≥37.5°C or <35.5°C) (exploratory outcome) Treatment for neonatal jaundice (defined as peak total bilirubin of at least 15 mg or the use of phototherapy) (exploratory outcome) |
Maternal
Intensive care unit transfer High dependency level care Hyperstimulation or tachysystole (as defined by care givers) Hyperstimulation or tachysystole causing cardiotocograph (CTG) abnormality (as defined by care givers) Umbilical cord prolapse Birth outwith hospital Postpartum haemorrhage 1000 mL or more Maternal fever 38°C or more after commencing cervical ripening (exploratory outcome) |
| Effectiveness outcomes | Time from first cervical ripening agent to admission to labour ward/birth unit Time from first cervical ripening agent to birth More than one cervical ripening agent used Duration of antenatal hospital stay for cervical ripening Duration of labour ward admission until birth Duration postnatal hospital stay (mother) Total hospital stay Hours spent at home Oxytocin use Mode of birth Birth in obstetric unit Birth in alongside midwifery unit (if available at that site) | |
| Mother baby outcomes | Breastfeeding at discharge from maternity care Skin to skin at birth | |
| Cost effectiveness |
Primary health economic outcomes
Incremental cost per neonatal admissions avoided (home vs in-hospital) Incremental quality adjusted life year (QALYs) (home vs in-hospital) Other (exploratory) economic outcomes Incremental cost per hour prevented from hospital admission to delivery/birth Incremental cost per neonatal admission avoided (home balloon catheter vs home dinoprostone) Incremental cost per QALY (home balloon catheter vs home dinoprostone) Incremental cost per hour prevented from hospital admission to delivery/birth (home balloon catheter vs home dinoprostone) | |
| Outcomes to check comparability of groups/matching | Birth weight Birth weight centile Small for gestational age (<10th centile for gestational age) Large for gestational age (>90th centile for gestational age) | |
| Qualitative CHOICE process evaluation outcomes |
Primary qualitative outcome
Sense of control (agentry) in labour Secondary qualitative outcomes Women’s satisfaction with induction of labour care Women’s postnatal psychological well-being Women’s overall evaluation of their labour and birth experience (qualitative analysis) Costs incurred by the woman and family | |