Antenatal non-medical risk assessment and care pathways to improve pregnancy outcomes: a cluster randomized controlled trial

摘要

Background: Social deprivation negatively affects health outcomes. In addition to the negative impact of medical and obstetric risk factors, multiple studies have shown a strong association between non-medical risk factors and adverse pregnancy outcomes. Risk assessment and subsequent implementation of preventive measures in antenatal health care with the aim to reduce adverse pregnancy outcomes should, therefore, take both medical and non-medical risk factors into account. The aim of this study was to determine whether a combination of risk assessment for non-medical factors during pregnancy, with subsequent use of care pathways, and the institution of personalised preventive care decreases the incidence of adverse neonatal outcomes at birth. Methods: Cluster randomized controlled trial in 14 urban municipalities across the Netherlands. The combined intervention consisted of antenatal risk assessment, focused on non-medical risk factors, lifestyle factors, and medical risk factors, using the Rotterdam Reproductive Risk Reduction (R4U) scorecard, and the subsequent institution of risk-specific care pathways and multidisciplinary consultation between care providers from the curative and the public health sector. The primary outcome was delivery of a preterm and/or a small for gestational age baby, analyzed with multilevel mixed-effects logistic regression analysis adjusting for cluster and individual baseline characteristics. Results: Data from 4302 participants across ten clusters was included in the intention to treat analysis. The intervention had no demonstrable impact on the primary outcome: adjusted odds ratio (aOR) 1.17 (95% CI 0.84 to 1.63). There was a statistically significant improvement in early detection of threatening preterm delivery and/or fetal growth restriction during pregnancy in the intervention clusters: aOR 1.27 (95% CI 1.01 to 1.61). Conclusions: Implementation of additional non-medical risk assessment and preventive strategies into general practices is feasible but did not decrease the incidence of our primary outcome in the index pregnancy in deprived urban areas.