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

Primary Purpose

Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text message surveillance
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pregnancy focused on measuring Influenza vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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

Sites / Locations

  • Columbia University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Text message monitoring

Arm Description

Use of text messaging to monitor post-vaccination

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
October 28, 2013
Last Updated
February 12, 2018
Sponsor
Columbia University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01974050
Brief Title
PregText: Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging
Official Title
PregText: Assessing the Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
Influenza vaccination

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text message monitoring
Arm Type
Other
Arm Description
Use of text messaging to monitor post-vaccination
Intervention Type
Behavioral
Intervention Name(s)
Text message surveillance
Primary Outcome Measure Information:
Title
Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of Participants Who Replied to Text Messaging to Assess Fever Frequency in the d0-2 Post-vaccination With IIV
Description
Number of enrollees who text temperature-related information for the d0-2 period post-vaccination
Time Frame
on vaccination day and the next 2 days (D0-2)
Title
Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy
Description
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
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
Number of Participants With a Fever in Days 0 to 2 Post-vaccination
Description
Number of participants with any fever on days 0 to 2 post-vaccination
Time Frame
2 days
Title
Pregnancy Complication
Description
Problems reported during pregnancy
Time Frame
9 months
Title
Pregnancy Outcome
Description
Pregnancy outcome including termination, preterm birth, term birth or stillbirth
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Stockwell, MD MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philip LaRussa, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Cano, MD MPH
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28495223
Citation
Stockwell MS, Cano M, Jakob K, Broder KR, Gyamfi-Bannerman C, Castano PM, Lewis P, Barrett A, Museru OI, Castellanos O, LaRussa PS. Feasibility of Text Message Influenza Vaccine Safety Monitoring During Pregnancy. Am J Prev Med. 2017 Sep;53(3):282-289. doi: 10.1016/j.amepre.2017.03.014. Epub 2017 May 8.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/28495223
Description
PubMed link

Learn more about this trial

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

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