Pregnancy
Conditions
Keywords
Influenza vaccination
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.
Interventions
BEHAVIORALText message surveillance
Sponsors
Centers for Disease Control and Prevention
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 enrollees who text temperature-related information for the d0-2 period post-vaccination |
| Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Fever in Days 0 to 2 Post-vaccination | 2 days | Number of participants with any fever on days 0 to 2 post-vaccination |
| Pregnancy Complication | 9 months | Problems reported during pregnancy |
| Pregnancy Outcome | 9 months | Pregnancy outcome including termination, preterm birth, term birth or stillbirth |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Text Message Monitoring Use of text messaging to monitor post-vaccination
Text message surveillance | 166 |
| Total | 166 |
Baseline characteristics
| Characteristic | Text Message Monitoring |
|---|---|
| Age, Customized 19-25 years | 38 Participants |
| Age, Customized 26-34 years | 75 Participants |
| Age, Customized 35-46 years | 53 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 96 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants |
| Race/Ethnicity, Customized Black | 15 Participants |
| Race/Ethnicity, Customized Indigenous Latin American | 7 Participants |
| Race/Ethnicity, Customized Multiracial | 21 Participants |
| Race/Ethnicity, Customized Other | 42 Participants |
| Race/Ethnicity, Customized White | 73 Participants |
| Sex: Female, Male Female | 166 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 166 |
| serious Total, serious adverse events | 0 / 166 |
Outcome results
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
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Text Message Monitoring | Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age | 166 Participants |
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
Time frame: on vaccination day and the next 2 days (D0-2)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Text Message Monitoring | Number of Participants Who Replied to Text Messaging to Assess Fever Frequency in the d0-2 Post-vaccination With IIV | 141 participants |
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
Time frame: 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Text Message Monitoring | Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy | 141 Participants |
Other Pre-specified
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
Time frame: 2 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Text Message Monitoring | Number of Participants With a Fever in Days 0 to 2 Post-vaccination | 1 Participants |
Other Pre-specified
Pregnancy Complication
Problems reported during pregnancy
Time frame: 9 months
Other Pre-specified
Pregnancy Outcome
Pregnancy outcome including termination, preterm birth, term birth or stillbirth
Time frame: 9 months