Opting In vs Opting Out
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/2/2018 |
| Start Date: | November 2010 |
| End Date: | August 2011 |
Opting In vs Opting Out: Impact on Influenza Vaccination in Pregnant Women
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.
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.
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.
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.
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
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials