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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 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. The trial reports 1 study location across 1 state.

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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.

Interventions

  • BEHAVIORAL Education
  • BIOLOGICAL Vaccine administration

Study Locations (1)

Rhode Island

  • Women and Infants Hospital - Providence

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2024-05-28
Est. Completion 2025-06-30
Phase Phase 4

What the Registry Record Tells You About NCT06135636

The ClinicalTrials.gov registry entry for NCT06135636 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Women and Infants Hospital of Rhode Island, which has 65 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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