NCT00593970

Brief Summary

Pregnant women have limited knowledge regarding influenza, its implications during pregnancy, and recommendations for vaccination during pregnancy. The researchers plan to distribute an information pamphlet to women in a prenatal clinic, offer the vaccine during prenatal visits, and then give a questionnaire on the postpartum floor assessing knowledge. The researchers hypothesize that with education intervention, knowledge scores on the questionnaire will be higher than those from last year, when no education was provided.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

5.9 years

First QC Date

January 3, 2008

Last Update Submit

February 20, 2019

Conditions

InfluenzaPregnancy

Keywords

influenzavaccinepregnancy

Outcome Measures

Primary Outcomes (1)

  • Knowledge scores on our questionnaire

    2 months

Study Arms (1)

1

All women presenting to our prenatal clinic and postpartum floor during the study period.

Eligibility Criteria

Age14 Years - 46 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A multi-ethnic group of pregnant women

You may qualify if:

  • all pregnant women

You may not qualify if:

  • known hypersensitivity to influenza vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Mark H Yudin, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

November 1, 2007

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations

CA(1)