Respiratory Syncytial Virus (RSV) and Vaccination in Pregnancy

University Hospital Southampton NHS Foundation Trust

Status: Unknown

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

Treatments: Other: Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT03096574

IRAS project ID: 220968

Details and patient eligibility

About

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

Full 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

Enrollment: 1,025 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,025 participants in 3 patient groups

Pregnant women

Description:

* 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

Treatment:

Other: Questionnaire

Maternity healthcare professionals

Description:

* 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

UK General Practitioners

Description:

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