WHO antenatal care randomised trial for the evaluation of a new model of routine antenatal care.

BACKGROUND: We undertook a multicentre randomised controlled trial that compared the standard model of antenatal care with a new model that emphasises actions known to be effective in improving maternal or neonatal outcomes and has fewer clinic visits. METHODS: Clinics in Argentina, Cuba, Saudi Arabia, and Thailand were randomly allocated to provide either the new model (27 clinics) or the standard model currently in use (26 clinics). All women presenting for antenatal care at these clinics over an average of 18 months were enrolled. Women enrolled in clinics offering the new model were classified on the basis of history of obstetric and clinical conditions. Those who did not require further specific assessment or treatment were offered the basic component of the new model, and those deemed at higher risk received the usual care for their conditions; however, all were included in the new-model group for the analyses, which were by intention to treat. The primary outcomes were low birthweight (<2500 g), pre-eclampsia/eclampsia, severe postpartum anaemia (<90 g/L haemoglobin), and treated urinary-tract infection. There was an assessment of quality of care and an economic evaluation. FINDINGS: Women attending clinics assigned the new model (n=12568) had a median of five visits compared with eight within the standard model (n=11958). More women in the new model than in the standard model were referred to higher levels of care (13.4% vs 7.3%), but rates of hospital admission, diagnosis, and length of stay were similar. The groups had similar rates of low birthweight (new model 7.68% vs standard model 7.14%; stratified rate difference 0.96 [95% CI -0.01 to 1.92]), postpartum anaemia (7.59% vs 8.67%; 0.32), and urinary-tract infection (5.95% vs 7.41%; -0.42 [-1.65 to 0.80]). For pre-eclampsia/eclampsia the rate was slightly higher in the new model (1.69% vs 1.38%; 0.21 [-0.25 to 0.67]). Adjustment by several confounding variables did not modify this pattern. There were negligible differences between groups for several secondary outcomes. Women and providers in both groups were, in general, satisfied with the care received, although some women assigned the new model expressed concern about the timing of visits. There was no cost increase, and in some settings the new model decreased cost. INTERPRETATIONS: Provision of routine antenatal care by the new model seems not to affect maternal and perinatal outcomes. It could be implemented without major resistance from women and providers and may reduce cost.

Methods for economic evaluation alongside a multicentre trial in developing countries: a case study from the WHO Antenatal Care Randomised Controlled Trial.

The WHO is testing a new rationalised programme of antenatal care in a multicentre randomised trial. The motivation for this trial arose from the current uncertainty about the effectiveness of different approaches to provision of routine antenatal care. Decision makers also lack information about the costs of providing routine antenatal care and the cost-effectiveness of one programme over another. Such information will be needed before the final choice of programme can be made. The WHO trial provides an ideal opportunity to estimate and compare the incremental costs and cost-effectiveness of the new programme in four countries (Argentina, Cuba, Saudi Arabia, Thailand). A separate economic component has been organised to measure the costs of antenatal care. Methods for cost identification and measurement, and methods for economic analysis in the context of an international study are based on current recommendations for the conduct of economic evaluations alongside trials. However, several aspects require further development. In particular, this includes defining standard methods for costing in different countries; measuring women's costs of access to care; and making comparisons across international settings. The economic evaluation will also inform similar multicentre international trials and investigate issues of generalisability beyond trial settings.

PIP: Economic estimations at the technology assessment stage of health interventions permit early recognition of the relative efficiencies of health care interventions and allow those that are expensive and have limited health effects to be discouraged from widespread adoption. The World Health Organization (WHO) Antenatal Care Randomized Controlled Trial includes a component aimed at estimating the incremental costs and cost-effectiveness of a new rationalized program of prenatal care relative to those associated with the standard prenatal care package. 2400 pregnant women attending 53 clinics in Argentina, Cuba, Thailand, and Saudi Arabia have been enrolled. The central concern is that the new program of prenatal care does not result in higher overall costs to either the health care system or women receiving care than the currently practiced model. Resources included in the unit cost estimation are staff, drugs and medications, materials, equipment, vehicles, utilities, and buildings and land. Monthly costing data are being collected at all study sites in Cuba and Thailand over a 12-month period and a questionnaire has been developed to assess the costs borne by women. Data from these two sources will be collated to produce tables of costs at the health facility, country, and international levels. The reliability of the results should be enhanced by the association of the economic analysis with a carefully designed randomized trial intended to minimize bias in terms of differences in the quantities of services used.