A Phase 4 interventional study of Education and Vaccine administration in Non-birthing Partner Vaccination in Pregnancy, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination and Vaccine Exposure During Pregnancy, sponsored by Women and Infants Hospital of Rhode Island. Recruiting at 1 site in United States. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-20.
Sponsored by Women and Infants Hospital of Rhode Island · Phase 4, Interventional, and Health services research
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:
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.
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 through antibody transmission across the placenta. However, when compared to relying on maternal vaccination alone, "cocooning"-the term for vaccinating all caregivers of newborns- is more effective in reducing neonatal morbidity and mortality from vaccine-related illnesses. Accordingly, the American College of Obstetrician and Gynecologist (ACOG) and Centers for Disease Control (CDC) both recommend that all caregivers be up-to-date on Tdap (Tetanus, Diphtheria and Pertussis), COVID-19, and influenza vaccinations to minimize risk of exposure of vaccine preventable diseases for postpartum individuals and neonates. Unfortunately, the majority of reproductive-aged individuals are not up to date on their routine vaccinations. For example, it is recommended that all adults ≥ 19 years old receive Tdap at least once in their lifetime with Td or Tdap boosters every 10 years; however, only 32.5% of reproductively aged individuals in the United States are vaccinated to TDAP.
The CDC has made calls for unique programs to minimize "missed opportunities," or when an eligible individual is at a health care encounter but fails to be vaccinated completely. Prenatal care is a time in which pregnant and non-pregnant reproductively aged individuals frequently participate in health care. Women who reported that a prenatal care provider offered vaccination in office or via referral were the most likely to receive a vaccination to influenza and Tdap compared to those who only received a vaccine recommendation or those who received no recommendation. This indicates that reducing barriers to vaccination (i.e. immediate in office vaccination), not just recommending vaccination, maximizes vaccine uptake. Prior small studies have demonstrated that the majority of parents of infants admitted to the Neonatal Intensive Care Unit and, in one small, non-randomized acceptability study, nearly two thirds of non-birthing partners accepted Tdap vaccination when offered during prenatal care. However, the majority of prenatal care providers do not offer vaccination to non-birthing partners due to administrative burden, a clear "missed opportunity" for vaccination. Programs expanding vaccine education and administration to non-birthing partners during routine prenatal care has yet to be explored, but such programs have the potential to improve perinatal and neonatal outcomes, thereby improving the health of multiple generations.
Investigators propose to implement a study of vaccine education and administration targeted specifically at Tdap vaccination for non-birthing partners of pregnant patients. The project will assess targeted educational tools for the counseling of non-birthing partners on Tdap recommendations and cocooning, as well as the impact of in-office vaccination opportunities on vaccine uptake for non-birthing partners during prenatal care.
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's planned enrollment of 150 is below the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →Women and Infants Hospital of Rhode Island is the lead sponsor of 93 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No up-front education, routine counseling as per their primary provider's standard practice, and written education on cocooning and recommendation for partner Tdap vaccination provided upon completion of the postpartum survey
Direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery
Behavioral: Education
Direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery plus the option to receive Tdap at their convenience at the WIH obstetric care clinic.
Behavioral: Education · Biological: Vaccine administration
Direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery
Option to receive Tdap at their convenience at the WIH obstetric care clinic provided to participant
Tdap vaccination rate for non-birthing partners
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.
Time frame: During pregnancy though 1 week postpartum
Dual vaccination rates for non-birthing partners
To assess whether non-birthing partners presenting for Tdap vaccination are willing to accept dual vaccination with Tdap and influenza.
Time frame: During pregnancy though 1 week postpartum
Plan to share: No — Data collected in this study will not be shared with other researchers.
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Jun 2025, 13 months after the start.
Of 21 phase 4 interventional studies under Diphtheria, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 30. This study's planned 13 months is below that.
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Women and Infants Hospital of Rhode Island