Zanamivir IV in Pregnancy Study
Research type
Research Study
Full title
Zanamivir 10mg/ml solution for infusion in pregnancy: an observational study of the safety of zanamivir 10mg/ml solution for infusion exposure in pregnant women with complicated influenza and their offspring.
IRAS ID
275464
Contact name
Janine de Haan
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Clinicaltrials.gov Identifier
EUPAS33189, EU PAS Number
Duration of Study in the UK
2 years, 3 months, 30 days
Research summary
Pregnant women are a group at risk of increased influenza-related complications and death. This prospective observational study aims to evaluate pregnancy outcomes among women who receive intravenous zanamivir (IVZ) treatment at any time during their pregnancy and has been requested by the European Medicines Agency.
This study will be a multi-centre, prospective, non-interventional, observational study in hospital maternity units in the United Kingdom as part of a European multi-country study.
Pregnant women with complicated influenza who have been treated with at least one dose of IVZ during their pregnancy will be eligible to participate in the study. Consent will be sought for inclusion of their data in the study, or, where women lack capacity through critical illness or have died, we will seek permission to collect information about them and their baby with consent from a proxy, or collect anonymous information only.
Women will not undergo any additional medical examinations or visits. The study will only collect data directly from healthcare providers based on information that is routinely documented in the participant’s medical record as part of usual clinical care. Data will be collected after exposure to IVZ, at the end of pregnancy (birth or pregnancy loss) and, where applicable, at three months after giving birth to obtain infant outcomes.
Information collected will include the following: 1) maternal death, 2) pregnancy outcomes including miscarriage, termination of pregnancy, stillbirth or live birth and 3) infant outcomes including birth weight, small for gestational age, gestational age at birth, congenital anomalies and neonatal death.
This study is primarily descriptive and designed to detect potential safety signals rather than test hypotheses. It is anticipated the study will continue until information on a total of 150 women has been collected.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
20/SC/0107
Date of REC Opinion
15 Jun 2020
REC opinion
Further Information Favourable Opinion