Influenza and Text Messaging in Pregnancy
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ClinicalTrials.gov Identifier: NCT01248520 |
Recruitment Status
:
Completed
First Posted
: November 25, 2010
Last Update Posted
: July 24, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pregnancy | Other: influenza and general health information Other: general health information | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 216 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Health Services Research |
Official Title: | Text Messaging For Preventative Health During Pregnancy; Improving Influenza Vaccination Rates In Pregnancy: A Randomized Controlled Trial of Text Messaging to Increase Vaccine Uptake |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | April 2014 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: General health information
Pregnant women receiving text messages containing general health messages without including information regarding the importance of the influenza vaccination
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Other: general health information
Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver.
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Active Comparator: Influenza and general health information
Pregnant women receiving text messages with influenza facts and the importance of the influenza vaccination, as well as general health messages Intervention: Text messages with influenza facts
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Other: influenza and general health information
Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver. These messages will contain general health information as well as information regarding influenza and the importance of vaccination during pregnancy.
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- To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. [ Time Frame: at participant post-partum visit ]To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. We hypothesize that text messaging will improve the timing (earlier in flu season) and rate of receipt of influenza vaccination in pregnancy.
- To assess the ability of direct education via text messaging to enhance knowledge about influenza infection and vaccination in pregnancy. [ Time Frame: at participant post-partum visit ]To assess the ability of direct education via text messaging to enhance knowledge about influenza infection and vaccination in pregnancy. We hypothesize that women receiving text messages will be more likely than controls to have accurate knowledge about pregnant women's increased susceptibility to influenza and about the vaccine's safety and efficacy in pregnancy.

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Ages Eligible for Study: | 14 Years to 50 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Pregnant women less than 28 weeks estimated gestation age
- Between 14-50 years of age
- Willing to provide informed consent and undergo necessary study procedures
Exclusion Criteria:
- Unwillingness or inability to receive text messages
- Receipt of the current season's influenza vaccine or plan to receive the influenza vaccine on the day of the enrollment visit
- Reported history of adverse reaction precluding receipt of the vaccine
- Unwillingness or inability to provide informed consent and comply with study criteria.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248520
United States, Pennsylvania | |
Magee-Womens Hospital of UPMC | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Michelle Moniz, MD | University of Pittsburgh |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Richard Beigi, Associate Professor, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT01248520 History of Changes |
Other Study ID Numbers: |
PRO09100504 |
First Posted: | November 25, 2010 Key Record Dates |
Last Update Posted: | July 24, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Richard Beigi, University of Pittsburgh:
Pregnancy Influenza Vaccination |
Additional relevant MeSH terms:
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |