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Randomized Controlled Trial
. 2018 Jun;33(6):579-589.
doi: 10.1007/s10654-018-0387-7. Epub 2018 Mar 31.

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

Jacqueline Lagendijk  1 , Amber A Vos  2 , Loes C M Bertens  2 , Semiha Denktas  3   4 , Gouke J Bonsel  5 , Ewout W Steyerberg  6   7 , Jasper V Been  2   8 , Eric A P Steegers  2
Affiliations
Randomized Controlled Trial

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

Jacqueline Lagendijk et al. Eur J Epidemiol. 2018 Jun.

Abstract

Social deprivation negatively affects health outcomes but receives little attention in obstetric risk selection. We investigated whether a combination of (1) risk assessment focused on non-medical risk factors, lifestyle factors, and medical risk factors, with (2) subsequent institution of risk-specific care pathways, and (3) multidisciplinary consultation between care providers from the curative and the public health sector reduced adverse pregnancy outcomes among women in selected urban areas in the Netherlands. We conducted a cluster randomised controlled trial in 14 urban municipalities across the Netherlands. Prior to the randomisation, municipalities were ranked and paired according to their expected proportion of pregnant women at risk for adverse outcomes at birth. The primary outcome was delivery of a preterm and/or small for gestational age (SGA) baby, analysed with multilevel mixed-effects logistic regression analysis adjusting for clustering and individual baseline characteristics. A total of 33 community midwife practices and nine hospitals participated throughout the study. Data from 4302 participants was included in the Intention To Treat (ITT) analysis. The intervention had no demonstrable impact on the primary outcome: adjusted odds ratio (aOR) 1.17 (95% CI 0.84-1.63). Among the secondary outcomes, the intervention improved the detection of threatening preterm delivery and fetal growth restriction during pregnancy [aOR 1.27 (95% CI 1.01-1.61)]. Implementation of additional non-medical risk assessment and preventive strategies into general practices is feasible but did not decrease the incidence of preterm and/or SGA birth in the index pregnancy in deprived urban areas.Trial registration Netherlands National Trial Register (NTR-3367).

Keywords: Epidemiology; Pregnancy; Prevention; Risk assessment; Risk factors.

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Conflict of interest statement

Conflict of interest

All authors have completed the Unified Competing Interest form (available on request from the corresponding author). The authors declare that they have no conflict of interest.

Ethical standards

The study was reviewed by the Medical Ethical Review Board of the Erasmus MC. The Board provided a waiver for the need to obtain consent at the individual level according to Dutch law as all procedures were essentially accepted care, and data were analysed anonymously (MEC-2012-322).

Figures

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Trial design
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Fig. 2
Flow diagram according to CONSORT statement
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