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临床试验/NCT01233804
NCT01233804已完成不适用

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

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2010年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
280
试验地点
2
主要终点
Vaccination rates

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

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

排除标准

  • •influenza vaccine contraindication

研究组 & 干预措施

Opting in

No Intervention

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.

Opting Out

Experimental

Women will sign a consent form only if they do not want to receive the flu vaccine.

干预措施: Opting Out (Other)

结局指标

主要结局

Vaccination rates

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Wootton

Assitant Professor - Ctr For Clnc Rsrch & Evidnc MD

The University of Texas Health Science Center, Houston

研究点 (2)

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