Group B Streptococcus: Attitudes to Immunisation in Pregnancy

NCT01982084 | Completed

• 1 other identifier: OVG2013/06
• Study Type: observational
• Target: 758
• Locations: 1 country
• Sites: 4

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.

Conditions

Immunisation During Pregnancy; Group B Streptococcus

Keywords

Group B streptococcus; Immunisation; Pregnancy; Attitudes

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Attitudes of pregnant women to participating in a clinical trial of a GBS vaccine

  Single time point at interview or focus group lasting on average 1-2 hours

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women aged 18 years and over of any gestation receiving antenatal care in the Oxford area (part one and two) or within Imperial college and St Georges's NHS trusts in London and Edinburgh Royal infirmary (part two). Maternity healthcare professionals (midwives and doctors)working in the above areas. Parents who have had a child with Group B streptococcal disease (part one only).

You may qualify if:

• 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

You may not qualify if:

• Volunteer is part of the study team at any of the study sites

Sponsors & Collaborators

• University of Oxford: lead
• St George's, University of London: collaborator
• University College, London: collaborator
• Imperial College London: collaborator
• Royal Infirmary of Edinburgh: collaborator

Study Sites (4)

Edinburgh Royal Infirmary

Edinburgh, United Kingdom

Location

Imperial College London

London, United Kingdom

Location

St Georges University of London

London, United Kingdom

Location

Oxford Vaccine Group, University of Oxford

Oxford, OX3 7LE, United Kingdom

Location

Related Publications (2)

• 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. Vaccine. 2016 Jul 25;34(34):4056-61. doi: 10.1016/j.vaccine.2016.06.024. Epub 2016 Jun 16.

  PMID: 27318418 RESULT

• 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 and healthcare professionals in the UK towards participation in clinical trials and routine implementation. Acta Obstet Gynecol Scand. 2018 Mar;97(3):330-340. doi: 10.1111/aogs.13288. Epub 2018 Jan 19.

  PMID: 29292509 RESULT

MeSH Terms

Conditions

Behavior

Study Officials

• Matthew Snape, MBBS FRCPCH

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: November 13, 2013
• Study Start: January 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 29, 2014
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

GB (4)