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NCT06135636 · ClinicalTrials.gov registry record · Phase 4
Assessing Interventions to Increase Tdap Acceptance for Non-birthing Partners in Pregnancy
A Phase 4 study of Vaccine Exposure During Pregnancy and Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, sponsored by Women and Infants Hospital of Rhode Island.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06135636: Recruiting Phase 4 study of Vaccine Exposure During Pregnancy and Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, sponsored by Women and Infants Hospital of Rhode Island.
NCT06135636 is a Phase 4 study of Vaccine Exposure During Pregnancy and Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination that is actively recruiting participants, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 150 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06135636, a Phase 4 study of Vaccine Exposure During Pregnancy and Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, is actively recruiting participants, sponsored by Women and Infants Hospital of Rhode Island.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Education
- BIOLOGICAL Vaccine administration
Study Locations (1)
Rhode Island
- Women and Infants Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-05-28 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 4 |
What NCT06135636 shows while recruiting
NCT06135636 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
The record links to 3 conditions, with Vaccine Exposure During Pregnancy appearing as the primary indexed condition, and to 2 interventions - of which Education is the first listed.
NCT06135636 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT06135636 about?
NCT06135636 is a clinical study titled "Assessing Interventions to Increase Tdap Acceptance for Non-birthing Partners in Pregnancy". 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 co...
What is the current status of trial NCT06135636?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2024-05-28. Estimated completion is 2025-06-30.
What conditions does trial NCT06135636 study?
This clinical trial studies the following conditions: Vaccine Exposure During Pregnancy, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, Non-birthing Partner Vaccination in Pregnancy.
What interventions are being tested in trial NCT06135636?
The interventions under investigation include: Education (BEHAVIORAL), Vaccine administration (BIOLOGICAL).
Who is sponsoring clinical trial NCT06135636?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06135636 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06135636's enrollment target sits among peer trials
150 533rd of 2000 higher than 1,437 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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