Opting In vs Opting Out

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01233804
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : June 28, 2013
Gilstrap, Larry C, M.D.
Information provided by (Responsible Party):
Susan Wootton, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Influenza Vaccination Other: Opting Out Not Applicable

Detailed Description:
Pregnant women who present for routine prenatal care when influenza vaccine is available would be eligible. Enrolled women would be randomized to either the Opting in (obtaining written consent to administer the vaccine) or Opting out (signing only to refuse the vaccine) study group (Part 1). Vaccine uptake rate and reason for refusal will be captured for enrollees. At the end of this clinic visit, enrollees will be asked if they are interested in participating in Part 2 and 3 of the study. If yes, consent will be obtained. Part 2 of the study, a random sample of 50 women will be called 2 days after enrollment to determine 1) vaccine side effects 2) recall of information provided in consent and 3) to confirm next followup visit with Obstetrician. During Part 3, at 6 weeks post EDD (estimated due date), data about episodes of respiratory illness in the mothers and their infants occuring between the time when influenza vaccine was offered (Part 1) and 6 weeks post-EDD will be abstracted using a standard form. Data will be collected retrospectively by research nurses.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Opting In vs Opting Out: Impact on Influenza Vaccination in Pregnant Women
Study Start Date : November 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Opting in
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.
Experimental: Opting Out
Women will sign a consent form only if they do not want to receive the flu vaccine.
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.

Primary Outcome Measures :
  1. Vaccination rates [ Time Frame: up to 24 weeks ]
    Vaccination rates will be analyzed for the two groups (opting in vs opting out) to determine group vaccination rate.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • influenza vaccine contraindication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01233804

United States, Texas
University of Texas Medical Branch, Women's Clinics
Galveston, Texas, United States, 77555
University of Texas Health Science Center at Houston, Professional Building
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Gilstrap, Larry C, M.D.
Principal Investigator: Susan H Wootton, MD The University of Texas Health Science Center, Houston

Responsible Party: Susan Wootton, Assitant Professor - Ctr For Clnc Rsrch & Evidnc MD, The University of Texas Health Science Center, Houston Identifier: NCT01233804     History of Changes
Other Study ID Numbers: HSC-MS-10-0557
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013

Keywords provided by Susan Wootton, The University of Texas Health Science Center, Houston:
influenza vaccination rates

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs