Immunisation During PregnancyNCT01982084
Group B Streptococcus: Attitudes to Immunisation in Pregnancy
An observational study of Immunisation During Pregnancy and Group B Streptococcus, run by University of Oxford at 4 sites in United Kingdom.
Trial summary
Group B Streptococcus (GBS) is the commonest cause of severe infection and meningitis in babies under 3 months in the United Kingdom (UK). About one in ten babies with GBS infection die and half of babies with GBS meningitis are left with long term problems with their development. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunisation During Pregnancy, Group B Streptococcus
- How many people
- 758 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jan 2014to 29 Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women aged 18 years and over of any gestation receiving antenatal care in the Oxford area (part one and two) or within Imperial college and St Georges's NHS trusts in London and Edinburgh Royal infirmary (part two). Maternity healthcare professionals (midwives and doctors)working in the above areas. Parents who have had a child with Group B streptococcal disease (part one only).
Who may be able to join
- Pregnant women aged 18 years and above who have not previously had a child with GBS disease and are willing and able to give written, informed consent and are able to read and speak English. OR
- Obstetricians (including consultants and trainees) or midwives working at one of the study site who are willing and able to give written, informed consent OR
- Parents (mothers or fathers) of children who have had GBS disease (early or late onset), potentially including parents of children who have died from GBS disease who are willing and able to given written, informed consent Able to read and speak English
Who cannot join
- The inclusion criteria are not met
- Volunteer is part of the study team at any of the study sites
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Edinburgh Royal Infirmary
Edinburgh
Imperial College London
London
St Georges University of London
London
Oxford Vaccine Group, University of Oxford
Oxford, OX3 7LE
About this study
Official title: Attitudes to Immunisation Against Group B Streptococcus During Pregnancy in England and Scotland
Group B Streptococcus (GBS) is the commonest cause of severe infection and meningitis in babies under 3 months in the United Kingdom (UK). About one in ten babies with GBS infection die and half of babies with GBS meningitis are left with long term problems with their development.
Vaccinating pregnant women against GBS in order to protect their newborn babies is a promising area of research.However, many women are reluctant to accept vaccination during pregnancy for fear it will harm their unborn child and there is often a lack of understanding of both the vaccine and the condition it aims to prevent. Nevertheless, the recent positive experience of immunisation against pertussis in the United Kingdom, suggest that antenatal immunisation can be acceptable.
Read more
Previous research has shown that advice from maternity healthcare professionals regarding vaccination is highly valued by pregnant women so it is also important to explore the attitudes and opinions of this group.
The objective of this study is to assess the knowledge and attitudes of pregnant women and maternity healthcare professionals in England and Scotland regarding GBS disease and the acceptability of a potential vaccine.
There are two parts to this study. The first part will invite pregnant women, maternity healthcare professionals and parents who have had a child affected by GBS disease to take part in either a focus group or an individual interview.
This will allow for an in-depth exploration of the participants thoughts and opinions about GBS and vaccination in pregnancy. This part of the study will take place at the Oxford site only. The results will guide the development of a self completed, paper questionnaire which will be distributed to a wider range of pregnant women and maternity healthcare professionals across four different study sites.
This study has been funded by Meningitis UK. Additional collaborators to those listed include the charity Group B Strep Support.
- Keywords
- Group B streptococcus, Immunisation, Pregnancy, Attitudes
- Medical subject headings
- Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
The attitudes of pregnant women and maternity healthcare professionals towards vaccination against Group B streptococcus in pregnancy
The attitude of pregnant women and maternity healthcare professionals will be measured using their responses to questions asked during interviews or focus groups
Measured: Single timepoint at interview or focus group lasting on average 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completion29 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immunisation During PregnancyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 758 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- St George's, University of London, University College, London, Imperial College London, Royal Infirmary of Edinburgh
- Responsible party
- Sponsor
- Investigators
- Matthew Snape, MBBS FRCPCH, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982084
- Sponsor's protocol ID
- OVG2013/06
- Status last verified
- Apr 2018
- First submitted
- 10 Oct 2013
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
McQuaid F, Pask S, Locock L, Davis E, Stevens Z, Plumb J, Snape MD. Attitudes towards antenatal vaccination, Group B streptococcus and participation in clinical trials: Insights from focus groups and interviews of parents and healthcare professionals. Vaccine. 2016 Jul 25;34(34):4056-61. doi: 10.1016/j.vaccine.2016.06.024. Epub 2016 Jun 16.
PubMed 27318418McQuaid F, Jones C, Stevens Z, Meddaugh G, O'Sullivan C, Donaldson B, Hughes R, Ford C, Finn A, Faust SN, Gbesemete D, Bedford H, Hughes S, Varghese AS, Heath PT, Snape MD. Antenatal vaccination against Group B streptococcus: attitudes of pregnant women and healthcare professionals in the UK towards participation in clinical trials and routine implementation. Acta Obstet Gynecol Scand. 2018 Mar;97(3):330-340. doi: 10.1111/aogs.13288. Epub 2018 Jan 19.
PubMed 29292509
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attitudes to Immunisation Against Group B Streptococcus During Pregnancy in England and Scotland
- ClinicalTrials.gov ID
- NCT01982084
- Acronym / sponsor ID
- OVG2013/06
- Keywords
- Group B streptococcus, Immunisation, Pregnancy, Attitudes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 758 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- St George's, University of London, University College, London, Imperial College London, Royal Infirmary of Edinburgh
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- 29 Mar 2014 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Group B Streptococcus (GBS) is the commonest cause of severe infection and meningitis in babies under 3 months in the United Kingdom (UK). About one in ten babies with GBS infection die and half of babies with GBS meningitis are left with long term problems with their development.
Vaccinating pregnant women against GBS in order to protect their newborn babies is a promising area of research.However, many women are reluctant to accept vaccination during pregnancy for fear it will harm their unborn child and there is often a lack of understanding of both the vaccine and the condition it aims to prevent. Nevertheless, the recent positive experience of immunisation against pertussis in the United Kingdom, suggest that antenatal immunisation can be acceptable.
Previous research has shown that advice from maternity healthcare professionals regarding vaccination is highly valued by pregnant women so it is also important to explore the attitudes and opinions of this group.
The objective of this study is to assess the knowledge and attitudes of pregnant women and maternity healthcare professionals in England and Scotland regarding GBS disease and the acceptability of a potential vaccine.
There are two parts to this study. The first part will invite pregnant women, maternity healthcare professionals and parents who have had a child affected by GBS disease to take part in either a focus group or an individual interview.
This will allow for an in-depth exploration of the participants thoughts and opinions about GBS and vaccination in pregnancy. This part of the study will take place at the Oxford site only. The results will guide the development of a self completed, paper questionnaire which will be distributed to a wider range of pregnant women and maternity healthcare professionals across four different study sites.
This study has been funded by Meningitis UK. Additional collaborators to those listed include the charity Group B Strep Support.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women aged 18 years and over of any gestation receiving antenatal care in the Oxford area (part one and two) or within Imperial college and St Georges's NHS trusts in London and Edinburgh Royal infirmary (part two). Maternity healthcare professionals (midwives and doctors)working in the above areas. Parents who have had a child with Group B streptococcal disease (part one only).
Key inclusion criteria (3 listed)
- Pregnant women aged 18 years and above who have not previously had a child with GBS disease and are willing and able to give written, informed consent and are able to read and speak English. OR
- Obstetricians (including consultants and trainees) or midwives working at one of the study site who are willing and able to give written, informed consent OR
- Parents (mothers or fathers) of children who have had GBS disease (early or late onset), potentially including parents of children who have died from GBS disease who are willing and able to given written, informed consent Able to read and speak English
Key exclusion criteria (2 listed)
- The inclusion criteria are not met
- Volunteer is part of the study team at any of the study sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The attitudes of pregnant women and maternity healthcare professionals towards vaccination against Group B streptococcus in pregnancy
Time frame: Single timepoint at interview or focus group lasting on average 1-2 hours
The attitude of pregnant women and maternity healthcare professionals will be measured using their responses to questions asked during interviews or focus groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Results publication: PubMed 27318418McQuaid F, Pask S, Locock L, Davis E, Stevens Z, Plumb J, Snape MD. Attitudes towards antenatal vaccination, Group B streptococcus and participation in clinical trials: Insights from focus groups and interviews of parents and healthcare professionals. Vaccine. 2016 Jul 25;34(34):4056-61. doi: 10.1016/j.vaccine.2016.06.024. Epub 2016 Jun 16.
- Results publication: PubMed 29292509McQuaid F, Jones C, Stevens Z, Meddaugh G, O'Sullivan C, Donaldson B, Hughes R, Ford C, Finn A, Faust SN, Gbesemete D, Bedford H, Hughes S, Varghese AS, Heath PT, Snape MD. Antenatal vaccination against Group B streptococcus: attitudes of pregnant women and healthcare professionals in the UK towards participation in clinical trials and routine implementation. Acta Obstet Gynecol Scand. 2018 Mar;97(3):330-340. doi: 10.1111/aogs.13288. Epub 2018 Jan 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Snape, MBBS FRCPCH principal investigator
University of Oxford
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunisation During Pregnancy and Group B Streptococcus, run by University of Oxford at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The attitudes of pregnant women and maternity healthcare professionals towards vaccination against Group B streptococcus in pregnancy (time frame: Single timepoint at interview or focus group lasting on average 1-2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01982084, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.