Group B Streptococcus: Attitudes to Immunisation in Pregnancy

Completed

• Conditions: Group B Streptococcus; Immunisation During Pregnancy

• Registration Number: NCT01982084
• Lead Sponsor: University of Oxford

Brief Summary

Group B Streptococcus (GBS) is the commonest cause of severe infection and meningitis in babies under 3 months in the United Kingdom (UK). About one in ten babies with GBS infection die and half of babies with GBS meningitis are left with long term problems with their development.

Vaccinating pregnant women against GBS in order to protect their newborn babies is a promising area of research.However, many women are reluctant to accept vaccination during pregnancy for fear it will harm their unborn child and there is often a lack of understanding of both the vaccine and the condition it aims to prevent. Nevertheless, the recent positive experience of immunisation against pertussis in the United Kingdom, suggest that antenatal immunisation can be acceptable.

Previous research has shown that advice from maternity healthcare professionals regarding vaccination is highly valued by pregnant women so it is also important to explore the attitudes and opinions of this group.

The objective of this study is to assess the knowledge and attitudes of pregnant women and maternity healthcare professionals in England and Scotland regarding GBS disease and the acceptability of a potential vaccine.

There are two parts to this study. The first part will invite pregnant women, maternity healthcare professionals and parents who have had a child affected by GBS disease to take part in either a focus group or an individual interview.

This will allow for an in-depth exploration of the participants thoughts and opinions about GBS and vaccination in pregnancy. This part of the study will take place at the Oxford site only. The results will guide the development of a self completed, paper questionnaire which will be distributed to a wider range of pregnant women and maternity healthcare professionals across four different study sites.

This study has been funded by Meningitis UK. Additional collaborators to those listed include the charity Group B Strep Support.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-13
• Study Start: 2014-01
• Primary Completion: 2014-03
• Study Completion: 2014-03-29
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 758

Inclusion Criteria

• Pregnant women aged 18 years and above who have not previously had a child with GBS disease and are willing and able to give written, informed consent and are able to read and speak English. OR
• Obstetricians (including consultants and trainees) or midwives working at one of the study site who are willing and able to give written, informed consent OR
• Parents (mothers or fathers) of children who have had GBS disease (early or late onset), potentially including parents of children who have died from GBS disease who are willing and able to given written, informed consent Able to read and speak English

Exclusion Criteria

• The inclusion criteria are not met
• Volunteer is part of the study team at any of the study sites

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The attitudes of pregnant women and maternity healthcare professionals towards vaccination against Group B streptococcus in pregnancy	Single timepoint at interview or focus group lasting on average 1-2 hours	The attitude of pregnant women and maternity healthcare professionals will be measured using their responses to questions asked during interviews or focus groups

Trial Locations

Locations (4)

Edinburgh Royal Infirmary; 🇬🇧 Edinburgh, United Kingdom

Oxford Vaccine Group, University of Oxford; 🇬🇧 Oxford, United Kingdom

Imperial College London; 🇬🇧 London, United Kingdom

St Georges University of London; 🇬🇧 London, United Kingdom