Brief Influenza Vaccine Education to Pregnant Women

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Infectious Disease; Influenza
• Intervention / Treatment: Other: Influenza Vaccine Intervention

• Study Type: Interventional
• Enrollment (Actual): 321
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Kwong Wah Hospital
  • Hong Kong, Hong Kong
    • Tsan Yuk Hospital
  • Hong Kong, Hong Kong
    • Pamela Youde Nethersole Eastern Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Food and Health Bureau, Hong Kong
• Investigators: Principal Investigator: Marie TARRANT, PhD, MPH, RN, The University of Hong Kong

Publications and helpful links

General Publications

• Wong VWY, Fong DYT, Lok KYW, Wong JYH, Sing C, Choi AY, Yuen CYS, Tarrant M. Brief education to promote maternal influenza vaccine uptake: A randomized controlled trial. Vaccine. 2016 Oct 17;34(44):5243-5250. doi: 10.1016/j.vaccine.2016.09.019. Epub 2016 Sep 22.
• Wong VW, Fong DY, Tarrant M. Brief education to increase uptake of influenza vaccine among pregnant women: a study protocol for a randomized controlled trial. BMC Pregnancy Childbirth. 2014 Jan 14;14:19. doi: 10.1186/1471-2393-14-19.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: January 17, 2013
• First Submitted That Met QC Criteria: January 18, 2013
• First Posted (Estimate): January 21, 2013

Study Record Updates

• Last Update Posted (Estimate): October 9, 2015
• Last Update Submitted That Met QC Criteria: October 7, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: influenza; pregnancy; infectious disease; influenza vaccines
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Orthomyxoviridae Infections; Infections; Communicable Diseases; Influenza, Human
• Other Study ID Numbers: PIV-INT-1