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Open Access Study protocol

Implementation of a cost-effective strategy to prevent neonatal early-onset group B haemolytic streptococcus disease in the Netherlands

Diny GE Kolkman12*, Marlies EB Rijnders1, Maurice GAJ Wouters2, M Elske van den Akker-van Marle3, CPB Kitty van der Ploeg1, Christianne JM de Groot2 and Margot AH Fleuren4

Author Affiliations

1 Department of Child Health, TNO, PO Box 2215, 2301 CE Leiden, The Netherlands

2 Department of Obstetrics and Gynaecology, VUmc, VU University Medical Centre, PO Box 7057 1007 MB Amsterdam, The Netherlands

3 Department of Medical decision making, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands

4 Department of Life Style, TNO, PO Box 2215, 2301 CE Leiden, The Netherlands

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BMC Pregnancy and Childbirth 2013, 13:155  doi:10.1186/1471-2393-13-155

Published: 30 July 2013

Abstract

Background

Early-onset Group B haemolytic streptococcus infection (EOGBS) is an important cause of neonatal morbidity and mortality in the first week of life. Primary prevention of EOGBS is possible with intra-partum antibiotic prophylaxis (IAP.) Different prevention strategies are used internationally based on identifying pregnant women at risk, either by screening for GBS colonisation and/or by identifying risk factors for EOGBS in pregnancy or labour. A theoretical cost-effectiveness study has shown that a strategy with IAP based on five risk factors (risk-based strategy) or based on a positive screening test in combination with one or more risk factors (combination strategy) was the most cost-effective approach in the Netherlands. IAP for all pregnant women with a positive culture in pregnancy (screening strategy) and treatment in line with the current Dutch guideline (IAP after establishing a positive culture in case of pre-labour rupture of membranes or preterm birth and immediate IAP in case of intra-partum fever, previous sibling with EOGBS or GBS bacteriuria), were not cost-effective. Cost-effectiveness was based on the assumption of 100% adherence to each strategy. However, adherence in daily practice will be lower and therefore have an effect on cost-effectiveness.

Method/Design

The aims are to: a.) implement the current Dutch guideline, the risk-based strategy and the combination strategy in three pilot regions and b.) study the effects of these strategies in daily practice. Regions where all the care providers in maternity care implement the allocated strategy will be randomised. Before the introduction of the strategy, there will be a pre-test (use of the current guideline) involving 105 pregnant women per region. This will be followed by a post-test (use of the allocated strategy) involving 315 women per region. The outcome measures are: 1.) adherence to the specific prevention strategy and the determinants of adherence among care providers and pregnant women, 2.) outcomes in pregnant women and their babies and 3.) the costs of each strategy in relation to the effects.

Discussion

This study will provide recommendations for the implementation of the most cost-effective prevention strategy for EOGBS in the Netherlands on the basis of feasibility in daily practice.

Trial registration

Dutch Trial Register, NTR3965

Keywords:
Early-onset Group B streptococcus; Prevention; Dutch maternity care; Implementation; Guidelines