Opting In vs Opting Out

NCT01233804 | Completed

• 1 other identifier: HSC-MS-10-0557
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

influenza vaccination rates

Outcome Measures

Primary Outcomes (1)

• Vaccination rates

  Vaccination rates will be analyzed for the two groups (opting in vs opting out) to determine group vaccination rate.

  time 0 of part one study visit

Study Arms (2)

Opting in

NO INTERVENTION

Currently, pregnant women have to sign a consent stating that they want the influenza vaccine (at the clinics where the study is being conducted). Therefore, this group is the same as usual care. However, women will then be asked if they would like to take part in parts 2 and 3 of the study.

Opting Out

EXPERIMENTAL

Women will sign a consent form only if they do not want to receive the flu vaccine.

Other: Opting Out

Interventions

Opting Out OTHER

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.

Opting Out

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant female age \>17 years
• presenting for routine PNC at UT Houston or UT Galveston
• pregnant during influenza season
• pregnant when influenza vaccine available

You may not qualify if:

• influenza vaccine contraindication

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Gilstrap, Larry C, M.D.: collaborator

Study Sites (2)

University of Texas Medical Branch, Women's Clinics

Galveston, Texas, 77555, United States

Location

University of Texas Health Science Center at Houston, Professional Building

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Susan H Wootton, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor - Ctr For Clnc Rsrch & Evidnc MD

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: November 3, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 31, 2018

Record last verified: 2018-05

Locations

US (2)