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21 March 2013
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| [ Print-friendly version ] |
| Maternal and perinatal outcomes of pandemic influenza in pregnancy |
| ISRCTN | ISRCTN44137563 |
| DOI | 10.1186/ISRCTN44137563 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Maternal and perinatal outcomes of pandemic influenza in pregnancy |
| Scientific title | Maternal and perinatal outcomes of pandemic influenza in pregnancy: a cohort study |
| Acronym | N/A |
| Serial number at source | HTA: 11/46/12, Version 3 12/09/12 |
| 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 More details can be found at http://www.hta.ac.uk/2887 Study protocol can be found at http://www.hta.ac.uk/2887 |
| Lay 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? We anticipate collecting anonymous data on approximately 500 women with influenza in pregnancy in a future pandemic. What does the study involve? This study will collect anonymous data only. The cohort of pregnant women infected with influenza will be identified through the UK Obstetric Surveillance System (UKOSS) network of nominated reporting clinicians in each consultant maternity unit in the UK. Doctors and midwives will be asked to report anonymous details of pregnant women with confirmed pandemic influenza admitted to their unit. Each month throughout the study, the information collected will be analysed to describe the pregnancy and other outcomes for women and their babies and to describe their treatment. These data will be compared with previously collected information about women who do not have influenza in pregnancy. These analyses will be used to develop guidance for prevention and treatment during the pandemic. What are the possible benefits and risks of participating? There will be no benefit to individual women of inclusion of their anonymous data in the study. However, the information will be used to improve care for women and babies in the future. This study will collect 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? The study will run from the National Perinatal Epidemiology Unit, University of Oxford. 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? Funding has been provided by the National Institute for Health Research Health technology Assessment programme (NIHR HTA). Who is the main contact? Professor Marian Knight marian.knight@npeu.ox.ac.uk |
| Ethics approval | NRES Committee East Midlands - Nottingham, 11/09/2012, ref: 12/EM/0365 |
| Study design | Cohort study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Pandemic influenza in pregnancy |
| Participants - inclusion criteria | The cohort will be all pregnant women in the UK admitted to hospital with confirmed pandemic influenza |
| Participants - exclusion criteria | Women not meeting the inclusion criteria will be excluded |
| Anticipated start date | 01/06/2012 |
| Anticipated end date | 31/05/2015 |
| Status of trial | Ongoing |
| Patient information material | There is no participant information sheet for this study as it uses anonymous data only. |
| Target number of participants | 500 |
| Interventions | 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. |
| Primary outcome measure(s) | Incidence of hospitalisation with pandemic influenza in pregnancy |
| Secondary outcome measure(s) |
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 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) ref: 11/46/12 |
| Trial website | |
| Publications | |
| Contact name | Prof Marian Knight |
| Address |
National Perinatal Epidemiology Unit
University of Oxford Old Rd campus |
| City/town | Oxford |
| Zip/Postcode | OX3 7LF |
| Country | United Kingdom |
| Sponsor | University of Oxford (UK) |
| Address |
Joint Research Office
Block 60 Churchill Hospital Old Road |
| City/town | Oxford |
| Zip/Postcode | OX3 7LE |
| Country | United Kingdom |
| Sponsor website: | http://www.ox.ac.uk/ |
| Date applied | 21/01/2013 |
| Last edited | 24/01/2013 |
| Date ISRCTN assigned | 24/01/2013 |
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