Analytical approach:
The analysis was based on one clinical trial (Taher, et al. 2011, see ‘Other Publications of Related Interest’ below for bibliographic details). The authors stated that the perspective was that of the UK NHS. The time horizon was the period from patient randomisation until hospital discharge.
Effectiveness data:
The evidence came from a randomised controlled trial. The population was women with a singleton or multiple pregnancy, presenting as cephalic between 36 and 41 weeks of gestation, with a modified Bishop score of less than seven, for whom the attending obstetrician deemed that induced labour was necessary. There were 81 women randomised to the gel group and 83 to the tablets group. The main clinical effectiveness estimate was the induction of labour and delivery.
Monetary benefit and utility valuations:
Not relevant.
Measure of benefit:
The primary outcome measure was the time between the induction of labour (treatment) and delivery, in minutes. Secondary outcomes included the requirement for oxytocin, incidence of uterine hyperstimulation, incidence of intrapartum foetal blood sampling, epidural requirement, mode of delivery, blood loss at delivery, incidence of maternal pyrexia, perineal lacerations requiring suturing, one- and five-minute Apgar scores, and the need for admission to neonatal care.
Cost data:
The main cost categories were antenatal care, labour care, assisted delivery or caesarean section, maternal complications, postnatal care, maternal high-dependency care, neonatal care, and drugs or medications. Occupancy of maternity and neonatal wards, resource use estimates, and daily costs were estimated by interviewing the trial hospital's staff and using its electronic data collection systems. The costs for each level of neonatal care were national Department of Health reference costs. Drug and medication costs were from the British National Formulary. All costs were in UK pounds sterling (£) at 2008 prices, adjusted using the NHS Hospital and Community Health Services pay and price index.
Analysis of uncertainty:
To capture the impact of uncertainty different scenarios were considered. The results were presented with bootstrap 95% confidence intervals, and cost-effectiveness acceptability curves were constructed, for each scenario.