Brief Influenza Vaccine Education to Pregnant Women

Study Overview
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Brief Summary
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The investigators will conduct a brief educational intervention to pregnant women who have not yet received the influenza vaccine in this pregnancy to improve the uptake of seasonal influenza vaccine.

Official Title
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A Randomized Controlled Trial of a Brief Educational Intervention to Increase Uptake of Influenza Vaccine Among Pregnant Women

Conditions
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Influenza, Infectious Disease, Pregnancy

Intervention / Treatment
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* Other: Influenza Vaccine Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: singleton pregnancy 18 years of age or older in at least the second trimester of pregnancy Cantonese speaking Hong Kong resident no serious medical or obstetrical complications have not yet received the influenza vaccine in this pregnancy staying in Hong Kong for at least two weeks after delivery. Exclusion Criteria: not entitled to health benefits in Hong Kong (NEP)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual outpatient antenatal care consists of routine checking of the maternal and foetal health by either clinic midwives or obstetricians along with health education to promote a healthy pregnancy. | |
| Experimental: Influenza Vaccine Intervention<br>The intervention group will receive a brief 5 to 10-minute educational talk by research nurse explaining the facts of influenza and influenza vaccine and answering participant questions. | Other: Influenza Vaccine Intervention<br>* The intervention will include a brief 5 to 10-minute educational talk by research nurse explaining the facts of influenza and influenza vaccine and answering participant questions. The educational intervention will focus on: (1) Hong Kong government's recommendation regarding influenza vaccine during pregnancy, (2) potential complications associated with influenza during pregnancy and for young infants, (3) safety of influenza vaccine for mother and foetus, and (4) potential benefits of influenza vaccine for mother and infant, and (5) where and how to get the influenza vaccine in Hong Kong.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of influenza vaccination | The proportion of influenza vaccination in the control and intervention groups | 2 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The influenza and influenza vaccine knowledge of participants | The influenza and influenza vaccine knowledge of participants in the control and intervention groups after receiving the intervention. | 2 weeks postpartum | 
| the proportion of participants initiating discussion about influenza vaccine with their health care provider |  | 2 weeks postpartum | 
| the proportion of participants seeking out influenza vaccine |  | 2 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza, influenza vaccines, infectious disease, pregnancy