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Assessing Interventions to Increase Tdap Acceptance for Non-birthing Partners in Pregnancy

NCT06135636 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-09-20

No results posted yet for this study

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 rates compared to usual care.

The main question\[s\] it aims to answer are:

* To assess whether compared to standard prenatal care, targeted prenatal education regarding Tdap vaccination recommendations with and without in office vaccination opportunities improves Tdap uptake among non-birthing partners of pregnant patients.
* To assess whether non-birthing partners presenting for Tdap vaccination are willing to accept dual vaccination with Tdap and influenza.

Participants will receive direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery with or without the option to receive Tdap at their convenience at the WIH obstetric care clinic.

If there is a comparison group: Researchers will compare "Upfront Education" and "Upfront Education and Vaccination Administration" to "Usual care" to see if education and/or the offer for vaccination in the office increases Tdap vaccine acceptance for non-birthing partners.

Conditions

  • Non-birthing Partner Vaccination in Pregnancy
  • Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
  • Vaccine Exposure During Pregnancy

Interventions

BEHAVIORAL

Education

Direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery

BIOLOGICAL

Vaccine administration

Option to receive Tdap at their convenience at the WIH obstetric care clinic provided to participant

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Laurie Griffin, MD/PhD · Women and Infants Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-28
Primary Completion
2025-06-30
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06135636 on ClinicalTrials.gov