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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974050
• Other study ID #: AAAM4906
• Status: Completed
• Phase: N/A
• First received: October 28, 2013
• Last updated: February 12, 2018
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2018
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza, Human
• Pregnancy

Intervention

Behavioral:
• Text message surveillance

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stockwell MS, Cano M, Jakob K, Broder KR, Gyamfi-Bannerman C, Castaño 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With a Fever in Days 0 to 2 Post-vaccination	Number of participants with any fever on days 0 to 2 post-vaccination	2 days
Other	Pregnancy Complication	Problems reported during pregnancy	9 months
Other	Pregnancy Outcome	Pregnancy outcome including termination, preterm birth, term birth or stillbirth	9 months
Primary	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	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	on vaccination day and the next 2 days (D0-2)
Secondary	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	9 months

External Links

•   PubMed link