- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03096574
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:
- 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.
- 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
Status
Intervention / Treatment
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:
- 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.
- 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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Christopher Wilcox
- Phone Number: 02381204956
- Email: christopher.wilcox@soton.ac.uk
Study Contact Backup
- Name: Christine Jones
- Phone Number: 023 8120 6663
- Email: c.e.jones@soton.ac.uk
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
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
General practitioners
- Fully-qualified and working in the UK
- Able to read and write in English and give fully informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pregnant women
|
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
|
|
UK General Practitioners
|
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
Collaborators
Investigators
- Study Chair: Christine Jones, University Hospital Southampton NHS Foundation Trust
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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