Brief Influenza Vaccine Education to Pregnant Women

NCT ID: NCT01772901

Last Updated: 2015-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

321 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-07-31

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.

Detailed Description

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Conditions

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Influenza Infectious Disease Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Influenza Vaccine Intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Food and Health Bureau, Hong Kong

OTHER_GOV

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Marie Tarrant

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie TARRANT, PhD, MPH, RN

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Kwong Wah Hospital

Hong Kong, , Hong Kong

Site Status

Pamela Youde Nethersole Eastern Hospital

Hong Kong, , Hong Kong

Site Status

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Tsan Yuk Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type DERIVED
PMID: 27667330 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24423245 (View on PubMed)

Other Identifiers

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PIV-INT-1

Identifier Type: -

Identifier Source: org_study_id

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