PregText: Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging

Study Overview
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Brief Summary
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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.

Official Title
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PregText: Assessing the Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging

Conditions
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Pregnancy

Intervention / Treatment
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* Behavioral: Text message surveillance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Text message monitoring<br>Use of text messaging to monitor post-vaccination | Behavioral: Text message surveillance<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age | 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Replied to Text Messaging to Assess Fever Frequency in the d0-2 Post-vaccination With IIV | Number of enrollees who text temperature-related information for the d0-2 period post-vaccination | on vaccination day and the next 2 days (D0-2) | 
| Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy | Feasibility of text messaging to monitor pregnancy outcomes through the end of pregnancy: Number of women enrollees who continue to text pregnancy-related outcomes through the end of their pregnancy | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza vaccination