Clinical trial NCT01982084: Group B Streptococcus: Attitudes to Immunisation in Pregnancy
Official title: Attitudes to Immunisation Against Group B Streptococcus During Pregnancy in England and Scotland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunisation During Pregnancy
Group B Streptococcus
Keywords: Group B streptococcus
Immunisation
Pregnancy
Attitudes
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: St George's, University of London
name: University College, London
name: Imperial College London
name: Royal Infirmary of Edinburgh
First posted: 2013-11-13
Enrollment: 758
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: The attitudes of pregnant women and maternity healthcare professionals towards vaccination against Group B streptococcus in pregnancy
timeFrame: Single timepoint at interview or focus group lasting on average 1-2 hours
Secondary outcomes:
Other outcomes:
measure: Attitudes of pregnant women to participating in a clinical trial of a GBS vaccine
timeFrame: Single time point at interview or focus group lasting on average 1-2 hours
Locations:
city: Edinburgh
country: United Kingdom
facility: Edinburgh Royal Infirmary
city: London
country: United Kingdom
facility: Imperial College London
city: London
country: United Kingdom
facility: St Georges University of London
city: Oxford
country: United Kingdom
facility: Oxford Vaccine Group, University of Oxford
Study officials:
affiliation: University of Oxford
name: Matthew Snape, MBBS FRCPCH
role: PRINCIPAL_INVESTIGATOR
References:
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. Vaccine. 2016 Jul 25;34(34):4056-61. doi: 10.1016/j.vaccine.2016.06.024. Epub 2016 Jun 16.
citation: 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.