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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26304
Enrollment
1260
Registered
2013-04-19
Start date
2013-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

preventie, groep B streptokokken ziekte pasgeborene, prevention, group B hemolytic streptococcus disease, implementation, implementatie

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 c
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.

Sponsors

TNO Child Health VUMC, Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Women who decline treatment according to the allocated strategy, will be treated in accordance with the current Dutch guideline.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactDiny G.E. Kolkman

TNO Department of Child Health PO Box 2215

diny.kolkman@tno.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)