Brief Influenza Vaccine Education to Pregnant Women
Primary Purpose
Influenza, Infectious Disease, Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Influenza Vaccine Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Influenza focused on measuring influenza, influenza vaccines, infectious disease, pregnancy
Eligibility Criteria
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)
Sites / Locations
- Kwong Wah Hospital
- Pamela Youde Nethersole Eastern Hospital
- Queen Mary Hospital
- Tsan Yuk Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Influenza Vaccine Intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The proportion of influenza vaccination
The proportion of influenza vaccination in the control and intervention groups
Secondary Outcome Measures
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.
the proportion of participants initiating discussion about influenza vaccine with their health care provider
the proportion of participants seeking out influenza vaccine
Full Information
NCT ID
NCT01772901
First Posted
January 17, 2013
Last Updated
October 7, 2015
Sponsor
The University of Hong Kong
Collaborators
Food and Health Bureau, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01772901
Brief Title
Brief Influenza Vaccine Education to Pregnant Women
Official Title
A Randomized Controlled Trial of a Brief Educational Intervention to Increase Uptake of Influenza Vaccine Among Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Food and Health Bureau, Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Infectious Disease, Pregnancy
Keywords
influenza, influenza vaccines, infectious disease, pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
321 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Influenza Vaccine Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Influenza Vaccine Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
The proportion of influenza vaccination
Description
The proportion of influenza vaccination in the control and intervention groups
Time Frame
2 weeks postpartum
Secondary Outcome Measure Information:
Title
The influenza and influenza vaccine knowledge of participants
Description
The influenza and influenza vaccine knowledge of participants in the control and intervention groups after receiving the intervention.
Time Frame
2 weeks postpartum
Title
the proportion of participants initiating discussion about influenza vaccine with their health care provider
Time Frame
2 weeks postpartum
Title
the proportion of participants seeking out influenza vaccine
Time Frame
2 weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie TARRANT, PhD, MPH, RN
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kwong Wah Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Tsan Yuk Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
27667330
Citation
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.
Results Reference
derived
PubMed Identifier
24423245
Citation
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.
Results Reference
derived
Learn more about this trial
Brief Influenza Vaccine Education to Pregnant Women
We'll reach out to this number within 24 hrs