Assessing Group B Streptococcus awareness in pregnancy. version :1
Research type
Research Study
Full title
Development and preliminary evaluation of a tool to assess Group B Streptococcus (GBS) disease awareness in pregnancy.
IRAS ID
152887
Contact name
Jeffrey Lucas
Contact email
Sponsor organisation
University of Hertfordshire
Clinicaltrials.gov Identifier
NCT/63033, Reference for communicating with the National Childbirth Trust
Duration of Study in the UK
3 years, 8 months, 17 days
Research summary
Group B Streptococcus (GBS) is the leading cause of severe neonatal disease in the United Kingdom (UK), causing long-term disabilities in 50% of survivors. However, little is known about maternal levels of awareness of this disease. A tool that assesses GBS awareness may provide midwives and pregnancy advocacy groups with a means to identify pregnant women with limited awareness for further education. The aim of this study is to develop and evaluate the reliability (measurement consistency) and preliminary validity (measuring what is intended) of a tool to assess GBS awareness during pregnancy. The tool development process will follow a six-phase study design comprising: a literature review to define and identify dimensions of awareness (phase 1). During phase 2, the researcher will develop item statements and assemble an expert advisory of four midwives and one member of the charity Group B Streptococcus Support (GBSS) to review the content of the items. Following expert advice, a draft questionnaire will be created and pilot tested among six work colleagues from the Luton and Dunstable (L&D) University Hospital. In phase 3, midwives and antenatal class facilitators will invite pregnant women attending antenatal clinics at the Luton and Dunstable University Hospital (L& D), or classes at Children Centres, and the National Childbirth Trust (NCT), to complete the questionnaire on paper or online. In addition, a web-based survey will be posted on the GBSS charity website to recruit more pregnant women. Phase 4 will involve coding and management of survey data. Phase 5 will involve survey data analysis using SPSS to identify reliable items to retain in the final tool, and also describe the levels of awareness of participants in relation to demographic characteristics. Phase 6 will discuss the study outcomes, and provide suggestions for further development of the tool.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
16/NW/0867
Date of REC Opinion
14 Dec 2016
REC opinion
Favourable Opinion