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

NCT01974050 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2018-03-12

Study results available
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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.

Conditions

  • Pregnancy

Interventions

BEHAVIORAL

Text message surveillance

Sponsors & Collaborators

Principal Investigators

  • Melissa Stockwell, MD MPH · Columbia University

  • Philip LaRussa, MD · Columbia University

  • Maria Cano, MD MPH · Centers for Disease Control and Prevention

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01974050 on ClinicalTrials.gov