Trial Outcomes & Findings for PregText: Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging (NCT NCT01974050)

NCT ID: NCT01974050

Last Updated: 2018-03-12

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

166 participants

Primary outcome timeframe

3 months

Results posted on

2018-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	Text Message Monitoring Use of text messaging to monitor post-vaccination Text message surveillance
Overall Study STARTED	166
Overall Study COMPLETED	141
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Text Message Monitoring n=166 Participants Use of text messaging to monitor post-vaccination Text message surveillance
Age, Customized 19-25 years	38 Participants n=99 Participants
Age, Customized 26-34 years	75 Participants n=99 Participants
Age, Customized 35-46 years	53 Participants n=99 Participants
Sex: Female, Male Female	166 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	96 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	70 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race/Ethnicity, Customized White	73 Participants n=99 Participants
Race/Ethnicity, Customized Black	15 Participants n=99 Participants
Race/Ethnicity, Customized Asian	8 Participants n=99 Participants
Race/Ethnicity, Customized Indigenous Latin American	7 Participants n=99 Participants
Race/Ethnicity, Customized Multiracial	21 Participants n=99 Participants
Race/Ethnicity, Customized Other	42 Participants n=99 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Text Message Monitoring n=207 Participants Use of text messaging to monitor post-vaccination Text message surveillance
Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age	166 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Text Message Monitoring n=166 Participants Use of text messaging to monitor post-vaccination Text message surveillance
Number of Participants Who Replied to Text Messaging to Assess Fever Frequency in the d0-2 Post-vaccination With IIV	141 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Text Message Monitoring n=166 Participants Use of text messaging to monitor post-vaccination Text message surveillance
Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy	141 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 days

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

Outcome measures

Outcome measures
Measure	Text Message Monitoring n=166 Participants Use of text messaging to monitor post-vaccination Text message surveillance
Number of Participants With a Fever in Days 0 to 2 Post-vaccination	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

Problems reported during pregnancy

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

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

Outcome measures

Outcome data not reported

Adverse Events

Text Message Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Melissa S. Stockwell

Columbia University

Phone: 212-342-5732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place