BackgroundInduction of labour (IOL) is one of the commonest obstetric interventions, with significant impact on both the individual woman and health service delivery. Outpatient IOL is an attractive option to reduce these impacts. To date there is little data comparing outpatient and inpatient IOL methods, and potential safety concerns (hyperstimulation) if prostaglandins, the standard inpatient IOL medications, are used in the outpatient setting. The purpose of this study was to assess feasibility, clinical effectiveness and patient acceptability of outpatient Foley catheter (OPC) vs. inpatient vaginal PGE2 (IP) for induction of labour (IOL) at term.MethodsWomen with an unfavourable cervix requiring IOL at term (N = 101) were randomised to outpatient care using Foley catheter (OPC, n = 50) or inpatient care using vaginal PGE2 (IP, n = 51). OPC group had Foley catheter inserted and were discharged overnight following a reassuring cardiotocograph. IP group received 2 mg/1 mg vaginal PGE2 if nulliparous or 1 mg/1 mg if multiparous. Main outcome measures were inpatient stay (prior to birth, in Birthing Unit, total), mode of birth, induction to delivery interval, adverse reactions and patient satisfaction.ResultsOPC group had shorter hospital stay prior to birth (21.3 vs. 32.4 hrs, p < .001), IP were more likely to achieve vaginal birth within 12 hours of presenting to Birthing Unit (53% vs. 28%, p = .01). Vaginal birth rates (66% OPC Vs. 71% IP), total induction to delivery time (33.5 hrs vs. 31.3 hrs) and total inpatient times (96 hrs OPC Vs. 105 hrs IP) were similar. OPC group felt less pain (significant discomfort 26% Vs 58%, p = .003), and had more sleep (5.8 Vs 3.4 hours, p < .001), during cervical preparation, but were more likely to require oxytocin IOL (88 Vs 59%, p = .001).ConclusionsOPC was feasible and acceptable for IOL of women with an unfavourable cervix at term compared to IP, however did not show a statistically significant reduction in total inpatient stay and was associated with increased oxytocin IOL.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN:12609000420246.

The high assessed-but-not-recruited rate highlights important issues with external validity and feasibility when conducting obstetric trials, including recruitment difficulties related to participant, clinician and trial factors. Assessed: recruited ratios and demographic and outcome differences need consideration in planning and interpretation of randomised trials.

An under-used but potentially useful strategy may be staged recruitment and consent. Despite the evidence supporting labour as a time requiring increased acuity for informed consent, there is little to suggest that this knowledge is being applied to current Australian HREC and RCT practices. We suggest that further practical guidelines be devised to aid researchers and human ethics committees.

BackgroundOlder adults with intellectual disability have high rates of lifestyle-related illness yet remain poorly engaged in physical activity and nutrition interventions. There is a need to clarify what types of healthy lifestyle interventions are feasible and effective to implement in this population and how outcome measures can best be tracked. This paper describes the pilot feasibility study protocol for implementing a 12-week physical activity and healthy eating program, ‘Get Healthy!’ with older adults with intellectual disability.MethodsThe primary study aims are to assess the feasibility of implementing and monitoring the ‘Get Healthy!’ program with adults with mild to moderate intellectual disability, aged 40 years and over, and their carers. Secondary study aims are to assess the impact of the intervention across the following parametres: body mass index, waist circumference, cardiovascular fitness, physical activity (amount and intensity) and sedentary behaviours, resting blood pressure, functional strength/capacity, dietary intake (energy intake, food group consumption and diet quality), dietary and physical activity knowledge, and quality of life. Between 8 and 10 participants in total will be recruited into the 12-week program that will be run in metropolitan NSW, Australia. A combination of objective and subjective measures will be used to assess program feasibility and impact at set timepoints (baseline, mid and end-program).DiscussionResults from the feasibility pilot will be used to refine the study methodology and ‘Get Healthy!’ program content for future use in a sufficiently powered trial. Findings may be of interest to a broad range of disability and allied health workers engaged in supporting and monitoring healthy lifestyle change in adults with intellectual disability.Trial registrationACTRN: ACTRN12618000349246. Registered March 8, 2018- Retrospectively registered, UTN: U1111-1209-3132.