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

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Behavioral: Text message surveillance

• Registration Number: NCT01974050
• Lead Sponsor: Columbia University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-10-28
• Study Start: 2013-11
• Study First Posted: 2013-11-01
• Primary Completion: 2014-12
• Study Completion: 2015-12
• Results First Submitted: 2017-08-04
• Results First Submitted QC: 2017-08-04
• Status Verified: 2018-02
• Results First Posted: 2018-02-09
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 166

Inclusion Criteria

1. Are pregnant with a gestational age of <20 weeks either by last menstrual period (LMP) and/or ultrasound
2. Are at least 18 years of age
3. Have a visit at a study site during the enrollment period
4. Receive IIV at that visit
5. Have a cell phone with text messaging capabilities
6. Are English or Spanish-speaking
7. Are willing to report via text message through end of pregnancy

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Exclusion Criteria

1. Decision to not continue with pregnancy
2. Any contraindication to receipt of inactivated influenza vaccines
3. Receipt LAIV (live attenuated influenza vaccine) at that visit
4. Previous receipt of IIV in this pregnancy
5. Presence of fever >=100.4F at time of vaccination;
6. Administration of any antipyretic in the 6-hour period prior to vaccination,
7. Stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever;
8. Patient only speaks a language other than English or Spanish
9. Patient does not have a cell phone with text messaging
10. Patient's inability to read text messages

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Text message monitoring	Text message surveillance	Use of text messaging to monitor post-vaccination

Primary Outcome Measures

Name	Time	Method
Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age	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

Secondary Outcome Measures

Name	Time	Method
Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy	9 months	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
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)	Number of enrollees who text temperature-related information for the d0-2 period post-vaccination

Trial Locations

Locations (1)

Columbia University; 🇺🇸 New York, New York, United States