Cervical ripening has been shown to reduce associated operative morbidity prior to induction of labour. Agents commonly employed for cervical ripening include prostaglandin analogues, although these are associated with several adverse effects such as abdominal pain, gastrointestinal upset and vaginal bleeding. This study examines Isosorbide mononitrate (IMN) as a cervical ripening agent, administered on an outpatient basis, in women prior to induction of labour. There is no evidence of its cost-effectiveness although it is hypothesised that, compared with placebo treatment, the use of IMN will result in a shorter inpatient stay before delivery, hence decreased costs to the health service, as well as greater maternal satisfaction. There is also evidence that IMN may eliminate fetal heart rate abnormalities compared to the placebo. Preliminary findings will be reported on in relation to a prospective economic evaluation conducted alongside a randomised controlled trial estimating the cost-effectiveness of IMN. Three hundred women scheduled for induction of labour at Princess Royal Maternity Hospital, Glasgow, will be recruited to the study. The cost differences between the two groups, the IMN and placebo groups, will be measured, valued and combined with the clinical effectiveness data from the trial. Data will be collected on the health service resources used in the treatment of each woman and infant during the period between randomisation and hospital discharge. Data will be obtained from the trial data collection forms as well as observational research to provide details of the resources and staff inputs required for the induction of labour, as well as staff time, tests, procedures, drugs and equipment entailed by complications. Current UK unit costs will be applied to each resource item to value total resource use in each arm of the trial. The economic evaluation will be conducted from a health service perspective and will take two forms; (i) an overall cost analysis and (ii) an incremental cost-effectiveness analysis, which will be expressed in several forms, for example, incremental cost per operative delivery prevented. In the absence of stochastic data for all variables, a series of multi-way sensitivity analyses will be undertaken to explore the implications of uncertainty on the base-case incremental cost-effectiveness ratios. In addition, cost-effectiveness acceptability curves will be constructed using the net benefits approach. All analyses will be performed with a microcomputer using Statistical Package for the Social Sciences (SPSS) software.
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