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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Women and Infants Hospital

Providence, Rhode Island, United States, 02920