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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Melissa Stockwell, MD, MPH, Columbia University
ClinicalTrials.gov Identifier:
NCT01974050
First received: October 28, 2013
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Pregnancy
Behavioral: Text message surveillance

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: PregText: Assessing the Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Feasibility of recruiting pregnant women <20 weeks gestational age [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    % of 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:
  • Feasibility of text messaging to assess fever frequency in the d0-2 post-vaccination with IIV [ Time Frame: on vaccination day and the next 2 days (D0-2) ] [ Designated as safety issue: No ]
    % of women enrollees who text temperature-related information for the d0-2 period post-vaccination

  • Feasibility of text messaging to monitor pregnancy outcomes through the end of pregnancy [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    % of women enrollees who continue to text pregnancy-related outcomes through the end of their pregnancy


Other Outcome Measures:
  • Fever [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Fever days 0 to 2 post-vaccination

  • Pregnancy complication [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Problems reported during pregnancy

  • Pregnancy outcome [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Pregnancy outcome including termination, preterm birth, term birth or stillbirth


Estimated Enrollment: 165
Study Start Date: November 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Text message monitoring
Use of text messaging to monitor post-vaccination
Behavioral: Text message surveillance

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974050

Locations
United States, New York
Columbia University
NY, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Melissa Stockwell, MD, MPH, Assistant Professor of Pediatrics and Population and Family Health, Columbia University
ClinicalTrials.gov Identifier: NCT01974050     History of Changes
Other Study ID Numbers: AAAM4906
Study First Received: October 28, 2013
Last Updated: November 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Influenza vaccination

ClinicalTrials.gov processed this record on November 20, 2014