Group B Streptococcus: Attitudes to Immunisation in Pregnancy

April 3, 2018 updated by: University of Oxford

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

758

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom
        • Edinburgh Royal Infirmary
      • London, United Kingdom
        • Imperial College London
      • London, United Kingdom
        • St Georges University of London
      • Oxford, United Kingdom, OX3 7LE
        • Oxford Vaccine Group, University of Oxford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The attitudes of pregnant women and maternity healthcare professionals towards vaccination against Group B streptococcus in pregnancy
Time Frame: 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
Single timepoint at interview or focus group lasting on average 1-2 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attitudes of pregnant women to participating in a clinical trial of a GBS vaccine
Time Frame: Single time point at interview or focus group lasting on average 1-2 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Imperial College London
University College, London
St George's, University of London
Royal Infirmary of Edinburgh

Investigators

  • Principal Investigator: Matthew Snape, MBBS FRCPCH, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 29, 2014

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OVG2013/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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