Effectiveness of score card-based antenatal risk selection, care pathways, and multidisciplinary consultation in the Healthy Pregnancy 4 All study (HP4ALL): study protocol for a cluster randomized controlled trial

BACKGROUND: Promotion of healthy pregnancies has gained high priority in the Netherlands because of relatively unfavorable perinatal outcomes. In response, a nationwide study, ‘Healthy Pregnancy 4 All’ (HP4ALL), has been initiated. Part of this study involves systematic and broadened antenatal risk assessment (the Risk Assessment substudy). Risk selection in current clinical practice is mainly based on medical risk factors. Despite the increasing evidence for the influence of nonmedical risk factors (social status, lifestyle or ethnicity) on perinatal outcomes, these risk factors remain highly unexposed. Systematic risk selection, combined with customized care pathways to reduce or treat detected risks, and regular and structured consultation between community midwives, gynecologists and other care providers such as social workers, is part of this study. METHODS/DESIGN: Neighborhoods in 14 municipalities with adverse perinatal outcomes above national and municipal averages are selected for participation. The study concerns a cluster randomized controlled trial. Municipalities are randomly allocated to intervention (n = 3,500 pregnant women) and control groups (n = 3,500 pregnant women). The intervention consists of systematic risk selection with the Rotterdam Reproductive Risk Reduction (R4U) score card in pregnant women at the booking visit, and referral to corresponding care pathways. A risk score, based on weighed risk factors derived from the R4U, above a predefined threshold determines structured multidisciplinary consultation. Primary outcomes of this trial are dysmaturity (birth weight < p10), prematurity (birth <37 weeks), and efficacy of implementation. DISCUSSION: The ‘HP4ALL’ study introduces a systematic approach in antenatal health care that may improve perinatal outcomes and, thereby, affect future health status of a new generation in the Netherlands. TRIAL REGISTRATION: Dutch Trial Registry ( NTR-3367) on 20 March 2012. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/1745-6215-16-8) contains supplementary material, which is available to authorized users.