Plain English Summary
Background and study aims
Evidence from the last influenza pandemic in 2009 showed that pregnant women were particularly vulnerable to severe infection. The aims of this study are, in a future influenza pandemic, to estimate the incidence of hospitalisation with pandemic-type influenza in pregnancy, and to describe the outcomes of pregnancy particularly in relation to specific treatments and according to whether women have received influenza immunisation.
Who can participate?
Women with influenza in pregnancy in a future pandemic
What does the study involve?
This study collects anonymous data only. The cohort of pregnant women infected with influenza are identified through the UK Obstetric Surveillance System (UKOSS) network of nominated reporting clinicians in each consultant maternity unit in the UK. Doctors and midwives are asked to report anonymous details of pregnant women with confirmed pandemic influenza admitted to their unit. Each month throughout the study, the information collected is analysed to describe the pregnancy and other outcomes for women and their babies and to describe their treatment. These data are compared with previously collected information about women who do not have influenza in pregnancy. These analyses are used to develop guidance for prevention and treatment during the pandemic.
What are the possible benefits and risks of participating?
There is no benefit to individual women of inclusion of their anonymous data in the study. However, the information is used to improve care for women and babies in the future. This study collects anonymous data only, after women have been admitted to hospital and treated. There are thus no risks to participants.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
The study was funded in 2012, but will only be activated in the event that there is a new influenza pandemic
Who is funding the study?
National Institute for Health Research Health Technology Assessment (UK)
Who is the main contact?
Prof. Marian Knight
marian.knight@npeu.ox.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 11/46/12, Version 3 12/09/12
Study information
Scientific title
Maternal and perinatal outcomes of pandemic influenza in pregnancy: a cohort study
Acronym
Study hypothesis
The hypothesis of this study is that in a future influenza pandemic, pregnant women will be at increased risk of poor maternal and pregnancy outcomes, and a rapid study of this susceptible group will be important to inform both ongoing preventive and management policies.
Further details of the UK-wide Obstetric Surveillance System (UKOSS) which will be used to collect these data can be found on www.npeu.ox.ac.uk/ukoss
Ethics approval
NRES Committee East Midlands - Nottingham, 11/09/2012, ref: 12/EM/0365
Study design
Cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
There is no participant information sheet for this study as it uses anonymous data only
Condition
Pandemic influenza in pregnancy
Intervention
Observational study of pregnancy outcomes in women hospitalised with the pandemic influenza. Outcomes following extra corporeal membrane oxygenation (ECMO) and influenza immunisation will be described.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Incidence of hospitalisation with pandemic influenza in pregnancy
Secondary outcome measures
1. Maternal death
2. Level 3 critical care unit admission
3. Other major complication
4. Preterm birth
5. Congenital anomaly
6. Stillbirth
7. Early neonatal death
8. Perinatal death
Overall trial start date
01/06/2012
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All pregnant women in the UK admitted to hospital with confirmed pandemic influenza
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
500
Participant exclusion criteria
Women not meeting the inclusion criteria
Recruitment start date
01/06/2012
Recruitment end date
31/05/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Oxford
Oxford
OX3 7LF
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Joint Research Office
Block 60
Churchill Hospital
Old Road
Oxford
OX3 7LE
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/25834863