Condition category
Respiratory
Date applied
21/01/2013
Date assigned
24/01/2013
Last edited
24/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marian Knight

ORCID ID

Contact details

National Perinatal Epidemiology Unit
University of Oxford
Old Rd campus
Oxford
OX3 7LF
United Kingdom

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

More details can be found at http://www.hta.ac.uk/2887
Study protocol can be found at http://www.hta.ac.uk/2887

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 measures

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

31/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

The cohort will be 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 will be excluded

Recruitment start date

01/06/2012

Recruitment end date

31/05/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

National Perinatal Epidemiology Unit
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

http://www.ox.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) ref: 11/46/12

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes