Clinical trial NCT03096574: Respiratory Syncytial Virus (RSV) and Vaccination in Pregnancy
Official title: Respiratory Syncytial Virus (RSV) and Vaccination in Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Syncytial Virus (RSV)
Maternal Vaccine Exposure
Attitude
Keywords: Respiratory Syncytial Virus (RSV)
Maternal vaccination
Attitudes
Pregnancy
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
name: University Hospitals Bristol and Weston NHS Foundation Trust
name: St George's Healthcare NHS Trust
First posted: 2017-03-30
Enrollment: 1025
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women and clinical staff at the four study sites

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

Eligibility criteria: 1. Pregnant women

   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

   Exclusion Criteria:
   * Women in active labour
   * Women deemed acutely unwell or distressed
2. Maternity healthcare professionals

   Inclusion Criteria:
   * 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

Primary outcomes:
measure: Answers to questionnaires
timeFrame: Until data collection complete (December 2017)
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol University Hospitals
city: London
country: United Kingdom
facility: St Georges Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
city: Southampton
country: United Kingdom
facility: University Hosital Southampton NHS Foundation Trust
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Christine Jones
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.