PregText: Assessing the Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age
研究概览
简要总结
In this study, the investigators will prospectively assess fever rates and other adverse events in pregnant women after administration of inactivated influenza vaccine (IIV) using text messaging. The investigators hypothesize that women <20 weeks gestational age who receive IIV will be willing to enroll in a text messaging-based vaccine adverse event monitoring program and will use it to report fever in the post-vaccination period as well as continue to text pregnancy-related outcomes through the end of their pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Are pregnant with a gestational age of <20 weeks either by last menstrual period (LMP) and/or ultrasound
- •Are at least 18 years of age
- •Have a visit at a study site during the enrollment period
- •Receive IIV at that visit
- •Have a cell phone with text messaging capabilities
- •Are English or Spanish-speaking
- •Are willing to report via text message through end of pregnancy
排除标准
- •Decision to not continue with pregnancy
- •Any contraindication to receipt of inactivated influenza vaccines
- •Receipt LAIV (live attenuated influenza vaccine) at that visit
- •Previous receipt of IIV in this pregnancy
- •Presence of fever >=100.4F at time of vaccination;
- •Administration of any antipyretic in the 6-hour period prior to vaccination,
- •Stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever;
- •Patient only speaks a language other than English or Spanish
- •Patient does not have a cell phone with text messaging
- •Patient's inability to read text messages
研究组 & 干预措施
Text message monitoring
Use of text messaging to monitor post-vaccination
干预措施: Text message surveillance (Behavioral)
结局指标
主要结局
Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age
时间窗: 3 months
Number of eligible pregnant women \<20 weeks gestational age who receive IIV who will be willing to enroll in a text messaging-based vaccine adverse event monitoring program
次要结局
- Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy(9 months)
- Number of Participants Who Replied to Text Messaging to Assess Fever Frequency in the d0-2 Post-vaccination With IIV(on vaccination day and the next 2 days (D0-2))
研究者
Melissa Stockwell
Assistant Professor of Pediatrics and Population and Family Health
Columbia University