Maternal and perinatal outcomes of pandemic influenza in pregnancy
| ISRCTN | ISRCTN44137563 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44137563 |
| Secondary identifying numbers | HTA 11/46/12, Version 3 12/09/12 |
- Submission date
- 21/01/2013
- Registration date
- 24/01/2013
- Last edited
- 23/01/2023
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Respiratory
Plain English summary of protocol
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
Contact information
Scientific
National Perinatal Epidemiology Unit
University of Oxford
Old Road Campus
Oxford
OX3 7LF
United Kingdom
Study information
| Study design | Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | There is no participant information sheet for this study as it uses anonymous data only |
| Scientific title | Maternal and perinatal outcomes of pandemic influenza in pregnancy: a cohort study |
| Study objectives | 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(s) | NRES Committee East Midlands - Nottingham, 11/09/2012, ref: 12/EM/0365 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2012 |
| Completion date | 31/12/2020 |
| Reason abandoned (if study stopped) | Study redesigned and relaunched for COVID pandemic (see ISRCTN40092247) |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 500 |
| Key inclusion criteria | All pregnant women in the UK admitted to hospital with confirmed pandemic influenza |
| Key exclusion criteria | Women not meeting the inclusion criteria |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 31/05/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
OX3 7LF
United Kingdom
Sponsor information
University/education
Joint Research Office
Block 60
Churchill Hospital
Old Road
Oxford
OX3 7LE
England
United Kingdom
| Website | http://www.ox.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/03/2015 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
23/01/2023: The study status was changed to 'Stopped'.
25/04/2019: The overall trial end date was changed from 31/05/2015 to 31/12/2020.
04/08/2017: Publication reference added.
