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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text message monitoring | Other | Use of text messaging to monitor post-vaccination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text message surveillance | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pregnancy Complication | Problems reported during pregnancy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28495223 | Result | Stockwell MS, Cano M, Jakob K, Broder KR, Gyamfi-Bannerman C, Castano 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. doi: 10.1016/j.amepre.2017.03.014. Epub 2017 May 8. |
| Label | URL |
|---|---|
| PubMed link | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Text Message Monitoring | Use of text messaging to monitor post-vaccination Text message surveillance |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Text Message Monitoring | Use of text messaging to monitor post-vaccination Text message surveillance |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 3 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Text Message Monitoring | Use of text messaging to monitor post-vaccination Text message surveillance |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa S. Stockwell | Columbia University | 212-342-5732 | mss2112@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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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 |
| 9 months |
| Pregnancy Outcome | Pregnancy outcome including termination, preterm birth, term birth or stillbirth | 9 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | 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 | Posted | Number | participants | 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 | Posted | Count of Participants | Participants | 9 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | 2 days |
|
|
|
| Other Pre-specified | Pregnancy Complication | Problems reported during pregnancy | Not Posted | 9 months | Participants |
| Other Pre-specified | Pregnancy Outcome | Pregnancy outcome including termination, preterm birth, term birth or stillbirth | Not Posted | 9 months | Participants |
| 0 |
| 166 |
| 0 |
| 166 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |