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.|
|ClinicalTrials.gov Identifier: NCT01233804|
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : June 28, 2013
|Condition or disease||Intervention/treatment|
|Influenza Vaccination||Other: Opting Out|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Opting In vs Opting Out: Impact on Influenza Vaccination in Pregnant Women|
|Study Start Date :||November 2010|
|Primary Completion Date :||March 2011|
|Study Completion Date :||August 2011|
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.
- 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.
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 ClinicalTrials.gov 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|
|Principal Investigator:||Susan H Wootton, MD||The University of Texas Health Science Center, Houston|