N/A
Completed N=166
PregText: Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging
Source: ClinicalTrials.gov NCT01974050 ↗Enrolled (actual)
166
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age — 166 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age |
166 | — |
| SECONDARY Number of Participants Who Replied to Text Messaging to Assess Fever Frequency in the d0-2 Post-vaccination With IIV |
141 | — |
| SECONDARY Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy |
141 | — |
Eligibility Criteria
Inclusion Criteria
- Are pregnant with a gestational age of =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
Data sourced from ClinicalTrials.gov (NCT01974050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.