NCT03096574

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,025

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

2.4 years

First QC Date

March 24, 2017

Last Update Submit

November 15, 2018

Conditions

Respiratory Syncytial Virus (RSV)Maternal Vaccine ExposureAttitude

Keywords

Respiratory Syncytial Virus (RSV)Maternal vaccinationAttitudesPregnancy

Outcome Measures

Primary Outcomes (1)

  • Answers to questionnaires

    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)

Study Arms (3)

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

Other: Questionnaire

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

Interventions

QuestionnaireOTHER

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.

Pregnant women

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women and clinical staff at the four study sites

You may qualify if:

  • 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

You may not qualify if:

  • Women in active labour
  • Women deemed acutely unwell or distressed
  • 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
  • General practitioners
  • Fully-qualified and working in the UK
  • Able to read and write in English and give fully informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Bristol University Hospitals

Bristol, United Kingdom

RECRUITING

St Georges Hospital

London, United Kingdom

RECRUITING

Oxford University Hospitals

Oxford, United Kingdom

RECRUITING

University Hosital Southampton NHS Foundation Trust

Southampton, United Kingdom

COMPLETED

Related Publications (2)

  • 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.

    PMID: 30418358DERIVED

  • 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.

    PMID: 30401620DERIVED

MeSH Terms

Conditions

Behavior

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Christine Jones

    University Hospital Southampton NHS Foundation Trust

    STUDY CHAIR

Central Study Contacts

Christopher Wilcox

CONTACT

02381204956christopher.wilcox@soton.ac.uk

Christine Jones

CONTACT

023 8120 6663c.e.jones@soton.ac.uk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2017

First Posted

March 30, 2017

Study Start

June 1, 2017

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

November 19, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(4)