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

NCT01974050 | Completed Results

• 1 other identifier: AAAM4906
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Influenza vaccination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy

  9 months

Other Outcomes (3)

• Number of Participants With a Fever in Days 0 to 2 Post-vaccination

  2 days

• Pregnancy Complication

  9 months

• Pregnancy Outcome

  9 months

Study Arms (1)

Text message monitoring

OTHER

Use of text messaging to monitor post-vaccination

Behavioral: Text message surveillance

Interventions

Text message surveillance BEHAVIORAL

Text message monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 28495223 RESULT

Related Links

• PubMed link

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Melissa S. Stockwell
• Organization: Columbia University

mss2112@cumc.columbia.edu

212-342-5732

Study Officials

• Melissa Stockwell, MD MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Philip LaRussa, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Maria Cano, MD MPH

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics and Population and Family Health

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 1, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: March 12, 2018
• Results First Posted: February 9, 2018

Record last verified: 2018-02

Locations

US (1)