Status:
RECRUITING
Assessing Interventions to Increase Tdap Acceptance for Non-birthing Partners in Pregnancy
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Conditions:
Non-birthing Partner Vaccination in Pregnancy
Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Eligibility:
All Genders
19-50 years
Phase:
PHASE4
Brief Summary
The goal of this randomized control trial is to assess if prenatal vaccine education and in-office vaccination administration for non-birthing partners of pregnant patients increases Tdap vaccination ...
Detailed Description
Vaccination plays a critical role in decreasing the morbidity and mortality of vaccine-preventable diseases. During pregnancy, maternal vaccination increases neonatal immunity via passive immunity thr...
Eligibility Criteria
Inclusion
- Partners of pregnant patients who are receiving their prenatal care at the OGCC
- 19-50 years old: This age range was selected as 19 years is both the age at which adult Tdap vaccination is recommended by the CDC as well as the age for the State supplied adult Tdap and Influenza Vaccines. Fifty years old is the upper limit of "reproductively aged individuals, the target population for this study.
- Have not or are unsure if they have received the adult Tdap vaccine or booster in the last 10 years: In addition to the CDC recommendation for adult Tdap vaccination and Td or Tdap booster every 10 years, the CDC recommends vaccination for any adult who is unsure of their vaccination status to ensure they are vaccinated as repeat vaccination does not cause additional harm.
- Fluency in English or Spanish: Consents, surveys, and Tdap and cocooning information will be available in both languages.
Exclusion
- Latex allergy: Contraindication to the state supplied Tdap vaccine
- Lethal fetal anomaly diagnosed prior to enrollment to prevent undue distress with follow-up postpartum
Key Trial Info
Start Date :
May 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06135636
Start Date
May 28 2024
End Date
June 30 2025
Last Update
September 20 2024
Active Locations (1)
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1
Women and Infants Hospital
Providence, Rhode Island, United States, 02920