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Brief Influenza Vaccine Education to Pregnant Women

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ClinicalTrials.gov Identifier: NCT01772901
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : October 9, 2015
Sponsor:
Collaborator:
Food and Health Bureau, Hong Kong
Information provided by (Responsible Party):
Marie Tarrant, The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Influenza Infectious Disease Pregnancy Other: Influenza Vaccine Intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of a Brief Educational Intervention to Increase Uptake of Influenza Vaccine Among Pregnant Women
Study Start Date : October 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. The proportion of influenza vaccination [ Time Frame: 2 weeks postpartum ]
    The proportion of influenza vaccination in the control and intervention groups


Secondary Outcome Measures :
  1. The influenza and influenza vaccine knowledge of participants [ Time Frame: 2 weeks postpartum ]
    The influenza and influenza vaccine knowledge of participants in the control and intervention groups after receiving the intervention.

  2. the proportion of participants initiating discussion about influenza vaccine with their health care provider [ Time Frame: 2 weeks postpartum ]
  3. the proportion of participants seeking out influenza vaccine [ Time Frame: 2 weeks postpartum ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772901


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marie Tarrant, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01772901     History of Changes
Other Study ID Numbers: PIV-INT-1
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: October 2015

Keywords provided by Marie Tarrant, The University of Hong Kong:
influenza
influenza vaccines
infectious disease
pregnancy

Additional relevant MeSH terms:
Influenza, Human
Communicable Diseases
Infection
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs