Condition category
Respiratory
Date applied
21/01/2013
Date assigned
24/01/2013
Last edited
04/08/2017
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?
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

Contact information

Type

Scientific

Primary contact

Prof Marian Knight

ORCID ID

Contact details

National Perinatal Epidemiology Unit
University of Oxford
Old Road 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

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

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

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

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

Results - basic reporting

Publication summary

2015 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/25834863

Publication citations

Additional files

Editorial Notes

04/08/2017: Publication reference added.