Respiratory Syncytial Virus (RSV) and Vaccination in Pregnancy

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

Study Overview

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

Study Type

Observational

Enrollment (Anticipated)

1025

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

      • Bristol, United Kingdom
        • Recruiting
        • Bristol University Hospitals
        • Contact:
          • Jane Metz
      • London, United Kingdom
        • Recruiting
        • St Georges Hospital
        • Contact:
          • Anna Calvert
      • Oxford, United Kingdom
        • Recruiting
        • Oxford University Hospitals
        • Contact:
          • Kirsten Beadon
      • Southampton, United Kingdom
        • Completed
        • University Hosital Southampton NHS Foundation Trust

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pregnant women and clinical staff at the four study sites

Description

  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

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: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
UK General Practitioners
  • Fully-qualified general practitioners practicing in the UK
  • Able to read and write in English and give fully informed consent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Answers to questionnaires
Time Frame: Until data collection complete (December 2017)
The answers to the questionnaires will be analysed using statistical software to assess their knowledge of RSV, and identify factors that might affect their understanding of RSV and attitudes to being involved in hypothetical future trials and receiving the RSV vaccination.
Until data collection complete (December 2017)

Collaborators and Investigators

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

Investigators

  • Study Chair: Christine Jones, University Hospital Southampton NHS Foundation Trust

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.

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 (Actual)

June 1, 2017

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

March 24, 2017

First Posted (Actual)

March 30, 2017

Study Record Updates

Last Update Posted (Actual)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS project ID: 220968

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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