|- candidate number||14775|
|- NTR Number||NTR3965|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-apr-2013|
|- Secondary IDs||200320008 ZonMw|
|- Public Title||Implementation of a cost effective strategy to prevent neonatal infection by group B hemolytic streptococcus.|
|- Scientific Title||Implementation of a cost effective strategy to prevent neonatal infection by group B hemolytic streptococcus.|
|- ACRONYM||RESPoNSZ: Regionale Evaluatie van Strategieen ter Preventie van Neonatale groep B Streptokokken Ziekte|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Prevention, Implementation, Infant-newborn, Group B hemolytic streptococcus disease|
|- Inclusion criteria||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.|
|- Exclusion criteria||Women who decline treatment according to the allocated strategy, will be treated in accordance with the current Dutch guideline.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2013|
|- planned closingdate||1-apr-2014|
|- Target number of participants||1260|
|- Interventions||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.
|- Primary outcome||1. Percentage of pregnant women that was offered the allocated prevention strategy;|
2. Percentage adherence to the allocated prevention strategy by care providers;
3. Percentage adherence to the allocated prevention strategy by pregnant women.
|- Secondary outcome||1. GBS colonisation of the baby;|
2. Length of hospital stay of the pregnant woman (in days);
3. Length of hospital stay of baby (in days);
4. Level of hospital care (standard, medium, high);
5. Worries in pregnancy in general (Cambridge worry scale);
6. Worries in pregnancy in GBS (based on Cambridge worry scale);
7. Satisfaction with received care by parents during pregnancy, childbirth and first week after birth;
8. Completeness of use of the prevention strategies by care providers.
|- Timepoints||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.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. Diny G.E. Kolkman|
|- CONTACT for SCIENTIFIC QUERIES|| M.E.B. Rijnders|
|- Sponsor/Initiator ||TNO Quality of Life, Division of Child Health, Prevention and Physical Activity, VU University Medical Center|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||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.
|- Main changes (audit trail)|
|- RECORD||19-apr-2013 - 9-mei-2013|