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Opting In vs Opting Out

NCT01233804 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2018-05-31

No results posted yet for this study

Summary

The purpose of this study is to compare methods for consenting (opting in vs opting out) on influenza vaccine uptake rate in pregnant women. This study is designed to learn about the impact of influenza vaccination in pregnant women. This study will help gather knowledge about influenza vaccine side effects (if given) and whether the vaccine reduces the number of respiratory infection in mothers and their infants.

Conditions

  • Influenza Vaccination

Interventions

OTHER

Opting Out

Usual care is for pregnant women to sign a consent to get the influenza vaccine. The intervention is to offer a group of women the option to sign only when they refuse the influenza vaccine.

Sponsors & Collaborators

  • Gilstrap, Larry C, M.D.

    collaborator INDIV

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Susan H Wootton, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-03-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01233804 on ClinicalTrials.gov