Randomised controlled trials of behavioural nudges delivered through text messages to increase influenza and COVID-19 vaccines among pregnant women (the EPIC study): study protocol.

Publication date: Jul 12, 2023

Influenza and COVID-19 infections during pregnancy may have serious adverse consequences for women as well as their infants. However, uptake of influenza and COVID-19 vaccines during pregnancy remains suboptimal. This study aims to assess the effectiveness of a multi-component nudge intervention to improve influenza and COVID-19 vaccine uptake among pregnant women. Pregnant women who receive antenatal care at five tertiary hospitals in South Australia, Western Australia and Victoria will be recruited to two separate randomised controlled trials (RCTs). Women will be eligible for the COVID-19 RCT is they have received two or less doses of a COVID-19 vaccine. Women will be eligible for the influenza RCT if they have not received the 2023 seasonal influenza vaccine. Vaccination status at all stages of the trial will be confirmed by the Australian Immunisation Register (AIR). Participants will be randomised (1:1) to standard care or intervention group (n = 1038 for each RCT). The nudge intervention in each RCT will comprise three SMS text message reminders with links to short educational videos from obstetricians, pregnant women and midwives and vaccine safety information. The primary outcome is at least one dose of a COVID-19 or influenza vaccine during pregnancy, as applicable. Logistic regression will compare the proportion vaccinated between groups. The effect of treatment will be described using odds ratio with a 95% CI. Behavioural nudges that facilitate individual choices within a complex context have been successfully used in other disciplines to stir preferred behaviour towards better health choices. If our text-based nudges prove to be successful in improving influenza and COVID-19 vaccine uptake among pregnant women, they can easily be implemented at a national level. ClinicalTrials. gov Identifier NCT05613751. Registered on November 14, 2022.

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Concepts Keywords
Australia COVID-19
Influenza Influenza
Midwives Pregnancy
Nct05613751 Randomised controlled trial
Vaccinated RCT


Type Source Name
disease MESH influenza
disease MESH COVID-19
disease VO pregnant women
disease VO protocol
disease MESH infections
disease VO effectiveness
disease IDO intervention
disease VO COVID-19 vaccine
disease VO Optaflu
disease VO vaccine
disease VO vaccination
drug DRUGBANK Medical air
disease VO dose
disease VO vaccinated
drug DRUGBANK Tropicamide
pathway REACTOME Reproduction
drug DRUGBANK Ilex paraguariensis leaf
disease MESH death
disease MESH virus infection
drug DRUGBANK Coenzyme M
disease VO population
disease IDO infection
disease MESH pregnancy complications
disease MESH maternal death
disease MESH preeclampsia
disease MESH gestational diabetes
drug DRUGBANK Polyethylene glycol
disease VO time
disease IDO process
disease VO effective
disease MESH contraindications
drug DRUGBANK Ranitidine
disease MESH pregnancy outcome
drug DRUGBANK Trestolone
disease IDO quality
disease MESH emergency
disease VO USA
disease VO Canada
disease VO vaccine effectiveness
disease VO Comirnaty
drug DRUGBANK Honey
disease MESH Critical illness
disease MESH pertussis
pathway KEGG Pertussis
disease MESH Infectious diseases
disease IDO country
drug DRUGBANK Gold

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