NCT01772901

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 9, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

January 17, 2013

Last Update Submit

October 7, 2015

Conditions

InfluenzaInfectious DiseasePregnancy

Keywords

influenzainfluenza vaccinesinfectious diseasepregnancy

Outcome Measures

Primary Outcomes (1)

  • The proportion of influenza vaccination

    The proportion of influenza vaccination in the control and intervention groups

    2 weeks postpartum

Secondary Outcomes (3)

  • The influenza and influenza vaccine knowledge of participants

    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

Study Arms (2)

Control

NO INTERVENTION

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.

Influenza Vaccine Intervention

EXPERIMENTAL

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

Interventions

Influenza Vaccine InterventionOTHER

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.

Influenza Vaccine Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • singleton pregnancy
  • 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.

You may not qualify if:

  • not entitled to health benefits in Hong Kong (NEP)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kwong Wah Hospital

Hong Kong, Hong Kong

Location

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Tsan Yuk Hospital

Hong Kong, Hong Kong

Location

Related Publications (2)

  • 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.

    PMID: 27667330DERIVED

  • 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.

    PMID: 24423245DERIVED

MeSH Terms

Conditions

Influenza, HumanCommunicable Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marie TARRANT, PhD, MPH, RN

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 21, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

July 1, 2015

Last Updated

October 9, 2015

Record last verified: 2015-10

Locations

HK(4)