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Completed

NCT Number: NCT01974050

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

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.

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Key information

Conditions

Pregnancy Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text message surveillance

Behavioral

Primary outcomes

  1. Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age

    Time frame: 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 outcomes

  1. Number of Participants Who Replied to 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)

    Number of enrollees who text temperature-related information for the d0-2 period post-vaccination

  2. Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy

    Time frame: 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

Other outcomes

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

    Time frame: 2 days

    Number of participants with any fever on days 0 to 2 post-vaccination

  2. Pregnancy Complication

    Time frame: 9 months

    Problems reported during pregnancy

  3. Pregnancy Outcome

    Time frame: 9 months

    Pregnancy outcome including termination, preterm birth, term birth or stillbirth

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Nov 1, 2013
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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