Opting In vs Opting Out

Not Applicable

Completed

• Conditions: Influenza Vaccination
• Interventions: Other: Opting Out

• Registration Number: NCT01233804
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2010-10-27
• Study Start: 2010-11
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-03
• Primary Completion: 2011-03
• Study Completion: 2011-08
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opting Out	Opting Out	Women will sign a consent form only if they do not want to receive the flu vaccine.

Primary Outcome Measures

Name	Time	Method
Vaccination rates	time 0 of part one study visit	Vaccination rates will be analyzed for the two groups (opting in vs opting out) to determine group vaccination rate.

Trial Locations

Locations (2)

University of Texas Medical Branch, Women's Clinics; 🇺🇸 Galveston, Texas, United States

University of Texas Health Science Center at Houston, Professional Building; 🇺🇸 Houston, Texas, United States