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Implementation of a cost effective strategy to prevent neonatal infection by group B hemolytic streptococcus.

Recruiting
Conditions
preventie, groep B streptokokken ziekte pasgeborene, prevention, group B hemolytic streptococcus disease, implementation, implementatie
Registration Number
NL-OMON26304
Lead Sponsor
TNO Child HealthVUMC, Amsterdam
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
1260
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Percentage of pregnant women that was offered the allocated prevention strategy;<br /><br>2. Percentage adherence to the allocated prevention strategy by care providers;<br /><br>3. Percentage adherence to the allocated prevention strategy by pregnant women.
Secondary Outcome Measures
NameTimeMethod
1. GBS colonisation of the baby;<br /><br>2. Length of hospital stay of the pregnant woman (in days);<br /><br>3. Length of hospital stay of baby (in days);<br /><br>4. Level of hospital care (standard, medium, high);<br /><br>5. Worries in pregnancy in general (Cambridge worry scale);<br /><br>6. Worries in pregnancy in GBS (based on Cambridge worry scale);<br /><br>7. Satisfaction with received care by parents during pregnancy, childbirth and first week after birth;<br /><br>8. Completeness of use of the prevention strategies by care providers.
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