Different prevention strategies are used internationally to prevent Early-onset Group B haemolytic streptococcus infection (EOGBS). However, none of the preventive EOGBS strategies in place at present result in the complete prevention of EOGBS,…
Bron
Verkorte titel
Aandoening
preventie, groep B streptokokken ziekte pasgeborene, prevention, group B hemolytic streptococcus disease, implementation, implementatie
Ondersteuning
VUMC, Amsterdam
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
1. Percentage of pregnant women that was offered the allocated prevention strategy;<br>
2. Percentage adherence to the allocated prevention strategy by care providers;<br>
3. Percentage adherence to the allocated prevention strategy by pregnant women.
Achtergrond van het onderzoek
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.
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.
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.
Doel van het onderzoek
Different prevention strategies are used internationally to prevent Early-onset Group B haemolytic streptococcus infection (EOGBS). However, none of the preventive EOGBS strategies in place at present result in the complete prevention of EOGBS, either because the strategy is not fully effective in itself, or because it has drawbacks which may result in non-adherence by both care providers and pregnant women.
We hypothesize that adherence by both care providers and pregnant women is equal for the current Dutch guideline, an alternative prevention strategy based on identifying risk factors for EOGBS and a prevention strategy based on screening for GBS colonization. Thus, potential differences in cost-effectiveness of these strategies is not caused by level of the adherence.
Onderzoeksopzet
In the 35th week of pregnancy all pregnant women receive a questionnaire regarding information on background and worries in general and specific on GBS.
10 days after birth a questionnaire regarding received care and satisfaction with care during pregnancy, delivery and the first week after birth is send to the women.
Care providers register medical data from 30 weeks of pregnancy for all pregnant women in their care, up to 8 days after delivery.
Onderzoeksproduct en/of interventie
Three different prevention strategies are randomly allocated to three Obstetric collaboration groups (OCGs) in the Netherlands. OCGs consist of one hospital and 3 to 5 midwifery practices in primary care in the vicinity. The innovation strategy consists of:
1. Providing information: care providers and client information will be developed to enhance awareness;
2. Recruitment of coordinators: two coordinators will be assigned to introduce, guide, coordinate and monitor the implementation process for the allocated prevention strategy;
3. Training of professional care providers based on three components:
A. General information on theoretical background;
B. Discussion of allocated prevention strategy in detail;
C. Counselling of pregnant women and shared decision making.
Publiek
Department of Child Health<br>
PO Box 2215
Diny G.E. Kolkman
Leiden 2301 CE
The Netherlands
diny.kolkman@tno.nl
Wetenschappelijk
Department of Child Health<br>
PO Box 2215
Diny G.E. Kolkman
Leiden 2301 CE
The Netherlands
diny.kolkman@tno.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Three Obstetric collaboration groups (OCGs) are recruited for this study. The study consists of a pre-test and a post- test. The pre-test is conducted for a period of three months and assesses adherence to the current Dutch guideline in prevention of neonatal GBS disease. After the pre-test the innovation strategy is applied in the three regions, to start with random allocation to a prevention strategy combined with implementation activities in the OCG. The actual introduction of the three prevention strategies will start in August 2013. To determine the effects of the implementation of the three strategies, a post-test is performed over a period of six months. During both the pre-test and post-test, all midwives and obstetricians will prospectively register all pregnant women from 30 weeks of gestational age onwards. All pregnant women will receive information about the EOGBS prevention strategy in their region and permission is acquired on the basis of opting out. Women who decline to participate will be treated in accordance with the current Dutch guideline.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Women who decline treatment according to the allocated strategy, will be treated in accordance with the current Dutch guideline.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL3792 |
NTR-old | NTR3965 |
Ander register | ZonMw : 200320008 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |