To find the most cost effective GBS prevention strategy to reduce neonatal morbidity and mortality by GBS for the Netherlands.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage adherence to the different prevention strategies compared with the
percentage adherence to the current Dutch guideline.
Secondary outcome
Adherence of the prevention strategies, clinical and process outcomes, cost
effectiveness analysis of the different prevention strategies, experiences of
pregnant women and care providers.
Background summary
Current prevention in the Netherlands of early onset group B- hemolytic
streptococcus infection (EOGBS) within the first week of life can be improved.
Perinatal mortality among children with EOGBS is 9.2%.
Intrapartum Antibiotic Prophylaxis (IAP) is effective in prevention of vertical
transmission of GBS from mother to child. It is not clear which pregnant women
need treatment with IAP.
Different prevention strategies are available, based on either screening during
pregnancy on GBS carriership with the mother (screening strategy), risk
factors during labour associated with EOGBS (risk factor strategy) or a
combination of screening and risk factors (combination strategy).
A theoretical modelstudy of TNO showed the combination strategy to be most
costeffective strategy in the Netherlands. The riskfactor strategy was cost
effective too. The screening strategy, as in use in the USA, has the highest
effect in reduction of morbidity and mortality at highest costs.
The current Dutch guideline seemed not very cost effective. The modelstudy was
based on 100% adherence of the strategy. The question remains what cost
effectiveness of the different strategies is in daily practice.
In this study three strategies will be implemented in three regions and
compared on realtime cost effectiveness.
Study objective
To find the most cost effective GBS prevention strategy to reduce neonatal
morbidity and mortality by GBS for the Netherlands.
Study design
Implementation study.
Intervention: Implementation of three different GBS prevention strategies in
three regions in the Netherlands.
Study burden and risks
Pregnant women will be included from the 30 th week of pregnancy onward. In the
combination strategy a culture will be taken between 35 and 37 weeks of
pregnancy to detect GBS carriership. The culture will be taken during a regular
pregnancyconsult. There is no need for the pregnant women for a extra visit.
During the next consult de test result will be discussed with the pregnant
woman. There are no risks related to taking the culture.
Intrapartum antibiotic prophylaxis will be provided to GBS carriers with a risk
factor in the combination strategy and to all pregnant women with a risk factor
in the riskfactor strategy.
Antibiotic prophylaxis given intravenous, demands hospital admittance during
labour. In the third strategy, the revised Dutch guideline, no extra actions
are performed.
Pregnant women are asked to fill a form on decisional conflict during
pregnancy. After delivery mothers are asked to fill a form on satisfaction.
Wassenaarseweg 56
Leiden 2333 AL
NL
Wassenaarseweg 56
Leiden 2333 AL
NL
Listed location countries
Age
Inclusion criteria
Midwives, gynecologists and pediatricians working in one hospital and the region around this hospital. All pregnant women in care of the midwive or gynecologist in the hospital region from pregnancy week 30 onwards.
Exclusion criteria
Pregnant women who refuse the 'new' policy of GBS prevention are offered the care as usual.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL41673.058.12 |