Brief Influenza Vaccine Education to Pregnant Women

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772901
• Other study ID #: PIV-INT-1
• Status: Completed
• Phase: N/A
• First received: January 17, 2013
• Last updated: October 7, 2015
• Start date: October 2013
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Disease
• Influenza
• Influenza, Human
• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Kwong Wah Hospital	Hong Kong
Hong Kong	Pamela Youde Nethersole Eastern Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Tsan Yuk Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Food and Health Bureau, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of influenza vaccination	The proportion of influenza vaccination in the control and intervention groups	2 weeks postpartum	No
Secondary	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	No
Secondary	the proportion of participants initiating discussion about influenza vaccine with their health care provider		2 weeks postpartum	No
Secondary	the proportion of participants seeking out influenza vaccine		2 weeks postpartum	No