Group B Streptococcus: Attitudes to Immunisation in Pregnancy

Group B Streptococcus Clinical Trial

Official title:

Attitudes to Immunisation Against Group B Streptococcus During Pregnancy in England and Scotland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982084
• Other study ID #: OVG2013/06
• Status: Completed
• First received: October 10, 2013
• Last updated: April 3, 2018
• Start date: January 2014
• Est. completion date: March 29, 2014

Study information

• Verified date: April 2018
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 758
• Est. completion date: March 29, 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Group B Streptococcus
• Immunisation During Pregnancy

Locations

Country	Name	City	State
United Kingdom	Edinburgh Royal Infirmary	Edinburgh
United Kingdom	Imperial College London	London
United Kingdom	St Georges University of London	London
United Kingdom	Oxford Vaccine Group, University of Oxford	Oxford

Sponsors (5)

Lead Sponsor	Collaborator
University of Oxford	Imperial College London, Royal Infirmary of Edinburgh, St George's, University of London, University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

McQuaid F, Jones C, Stevens Z, Meddaugh G, O'Sullivan C, Donaldson B, Hughes R, Ford C, Finn A, Faust SN, Gbesemete D, Bedford H, Hughes S, Varghese AS, Heath PT, Snape MD. Antenatal vaccination against Group B streptococcus: attitudes of pregnant women a — View Citation

McQuaid F, Pask S, Locock L, Davis E, Stevens Z, Plumb J, Snape MD. Attitudes towards antenatal vaccination, Group B streptococcus and participation in clinical trials: Insights from focus groups and interviews of parents and healthcare professionals. Vac — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Attitudes of pregnant women to participating in a clinical trial of a GBS vaccine	The attitudes of pregnant women to participating in a clinical trial of a GBS vaccine and the potential barriers and motivations to participation and how these could be addressed will be measured using the responses to questions asked during hte interview/focus group sessions	Single time point at interview or focus group lasting on average 1-2 hours
Primary	The attitudes of pregnant women and maternity healthcare professionals towards vaccination against Group B streptococcus in pregnancy	The attitude of pregnant women and maternity healthcare professionals will be measured using their responses to questions asked during interviews or focus groups	Single timepoint at interview or focus group lasting on average 1-2 hours