Opting In vs Opting Out

Influenza Vaccination Clinical Trial

Official title:

Opting In vs Opting Out: Impact on Influenza Vaccination in Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233804
• Other study ID #: HSC-MS-10-0557
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: August 2011

Study information

• Verified date: May 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: August 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza Vaccination
• Influenza, Human

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Medical Branch, Women's Clinics	Galveston	Texas
United States	University of Texas Health Science Center at Houston, Professional Building	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Gilstrap, Larry C, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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