Respiratory Syncytial Virus (RSV) and Vaccination in Pregnancy

NCT ID: NCT03096574

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1025 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2019-11-30

Brief Summary

Respiratory Syncytial Virus (RSV) is the leading cause of chest infections (pneumonia and bronchiolitis) in young children, and is a major cause of admission to hospital and childhood death worldwide. One possible way to protect the mother and young infant from RSV infection is a vaccine given to women during pregnancy (maternal vaccination), which would pass protection to their unborn child. This may help to prevent RSV in the child's first few months of life when they are most vulnerable to infection.

There are two main aims to this study:

1. To pre-emptively gauge the knowledge of RSV and potential acceptability of such vaccines amongst pregnant women and healthcare staff working in midwifery and obstetrics, as well as their attitudes (facilitators and barriers) to being involved in hypothetical future research trials.

2. We also wish to gauge the attitudes to routinely recommended vaccines in pregnancy (pertussis and influenza)

The investigators propose to undertake a questionnaire-based study of randomly selected pregnant women and healthcare staff (over 16 years of age) at English teaching hospitals and GP practices. Pregnant women attending for ward reviews or antenatal clinics will approached and asked to complete an anonymous paper questionnaire lasting around 10 minutes. Healthcare staff will be approached in person, or via email, and asked to complete a slightly different questionnaire lasting around 5-10 minutes. No follow up will take place. Using statistical software, the investigators hope to identify factors that might affect patients' understanding of RSV and attitudes to being involved in hypothetical future trials and receiving routine vaccination

Detailed Description

Respiratory Syncytial Virus (RSV) is a very common virus that causes infection of the airways and lungs. It is the leading cause of chest infections (pneumonia and bronchiolitis) in young children, and is a major cause of admission to hospital and childhood death worldwide. Lots of research trials are being done into ways of preventing and treating RSV, however there is still no RSV vaccine approved for routine use. One possible way to protect the mother and young infant from RSV infection is a vaccine given to women during pregnancy, which would pass protection to their unborn child. This may help to prevent RSV in the child's first few months of life when they are most vulnerable to infection. There are two vaccines that are currently being tested in pregnant women around the world, including the UK.

There are two main aims to this study:

1. To pre-emptively gauge the knowledge of RSV and potential acceptability of such vaccines amongst pregnant women and healthcare staff working in midwifery and obstetrics, as well as their attitudes (facilitators and barriers) to being involved in hypothetical future research trials.

2. We also wish to gauge the attitudes to routinely recommended vaccines in pregnancy (pertussis and influenza)

The investigators propose to undertake a questionnaire-based study of randomly selected pregnant women and healthcare staff (over 16 years of age) at four English teaching hospitals. Pregnant women attending for ward reviews or antenatal clinics will approached and asked to complete an anonymous paper questionnaire lasting around 10 minutes. Healthcare staff will be approached in person, or via email, and asked to complete a slightly different questionnaire lasting around 5-10 minutes. No follow up will take place. Using statistical software, the investigators hope to identify factors that might affect patients' understanding of RSV and attitudes to being involved in hypothetical future trials and receiving routine vaccination

Conditions

Respiratory Syncytial Virus (RSV); Maternal Vaccine Exposure; Attitude

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Pregnant women

• Over the age of 16
• Under the care of staff working in: University Hospital Southampton NHS Foundation Trust, St Georges Healthcare NHS Trust, Oxford University Hospitals NHS Foundation Trust or University Hospitals Bristol NHS Foundation Trust
• Able to read and write in English and give fully informed consent

Questionnaire

Intervention Type: OTHER

The participants will be approached by a member of the study team and, following recruitment, participants will be asked to fill in a short paper or online questionnaire. Our estimated time for completion is 5-10 minutes, and this time will be stated at the start of the questionnaire. Having completed the questionnaire they will be free to leave without further follow up, and given the contact details of the investigators/research governance office whom they can contact if they have further questions or concerns.

Maternity healthcare professionals

• Over the age of 18
• Working in obstetrics or midwifery who regularly care for women in pregnancy at University Hospital Southampton NHS Foundation Trust, St Georges Healthcare NHS Trust, Oxford University Hospitals NHS Foundation Trust or University Hospitals Bristol NHS Foundation Trust
• Able to read and write in English and give fully informed consent

No interventions assigned to this group

UK General Practitioners

• Fully-qualified general practitioners practicing in the UK
• Able to read and write in English and give fully informed consent

No interventions assigned to this group

Interventions

Questionnaire

The participants will be approached by a member of the study team and, following recruitment, participants will be asked to fill in a short paper or online questionnaire. Our estimated time for completion is 5-10 minutes, and this time will be stated at the start of the questionnaire. Having completed the questionnaire they will be free to leave without further follow up, and given the contact details of the investigators/research governance office whom they can contact if they have further questions or concerns.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Over the age of 16
• Under the care of staff working in: University Hospital Southampton NHS Foundation Trust, St Georges Healthcare NHS Trust, Oxford University Hospitals NHS Foundation Trust or University Hospitals Bristol NHS Foundation Trust
• Able to read and write in English and give fully informed consent

• Over the age of 18
• Working in obstetrics or midwifery who regularly care for women in pregnancy at University Hospital Southampton NHS Foundation Trust, St Georges Healthcare NHS Trust, Oxford University Hospitals NHS Foundation Trust or University Hospitals Bristol NHS Foundation Trust
• Able to read and write in English and give fully informed consent

3. General practitioners

• Fully-qualified and working in the UK
• Able to read and write in English and give fully informed consent

Exclusion Criteria

• Women in active labour
• Women deemed acutely unwell or distressed

2. Maternity healthcare professionals

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

University Hospitals Bristol and Weston NHS Foundation Trust

OTHER

Sponsor Role: collaborator

St George's Healthcare NHS Trust

OTHER

Sponsor Role: collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Jones

Role: STUDY_CHAIR

University Hospital Southampton NHS Foundation Trust

Locations

Bristol University Hospitals

Bristol, , United Kingdom

Site Status: RECRUITING

St Georges Hospital

London, , United Kingdom

Site Status: RECRUITING

Oxford University Hospitals

Oxford, , United Kingdom

Site Status: RECRUITING

University Hosital Southampton NHS Foundation Trust

Southampton, , United Kingdom

Site Status: COMPLETED

Countries

United Kingdom

Central Contacts

Christopher Wilcox

Role: CONTACT

christopher.wilcox@soton.ac.uk

02381204956

Christine Jones

Role: CONTACT

c.e.jones@soton.ac.uk

023 8120 6663

Facility Contacts

Jane Metz

Role: primary

Anna Calvert

Role: primary

Kirsten Beadon

Role: primary

References

Wilcox CR, Calvert A, Metz J, Kilich E, MacLeod R, Beadon K, Heath PT, Khalil A, Finn A, Snape MD, Vandrevala T, Nadarzynski T, Coleman MA, Jones CE. Determinants of Influenza and Pertussis Vaccination Uptake in Pregnancy: A Multicenter Questionnaire Study of Pregnant Women and Healthcare Professionals. Pediatr Infect Dis J. 2019 Jun;38(6):625-630. doi: 10.1097/INF.0000000000002242.

Reference Type: DERIVED

PMID: 30418358 (View on PubMed)

Wilcox CR, Bottrell K, Paterson P, Schulz WS, Vandrevala T, Larson HJ, Jones CE. Influenza and pertussis vaccination in pregnancy: Portrayal in online media articles and perceptions of pregnant women and healthcare professionals. Vaccine. 2018 Nov 29;36(50):7625-7631. doi: 10.1016/j.vaccine.2018.10.092. Epub 2018 Nov 3.

Reference Type: DERIVED

PMID: 30401620 (View on PubMed)

Other Identifiers

IRAS project ID: 220968

Identifier Type: -

Identifier Source: org_study_id