SuspendedNot Applicable

An Adaptive Prenatal Intervention to Increase Childhood Vaccinations

Stopped: The study is suspended pending a protocol amendment.

United States770 participantsStarted 2024-04-27

Plain-language summary

This study will test whether proactively connecting expectant parents with factual vaccination information during pregnancy can build confidence in vaccinations and lead to timely vaccinations during pregnancy and once their child is born.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Nulliparous individuals (no prior live birth) * Singleton pregnancy (excludes twins, triplets, etc.) * No known fetal congenital malformations or genetic abnormalities * Not at known risk for preterm birth * In late second trimester during study recruitment period * Receive prenatal care at one of the study practices Inclusion Criteria for Nested Sub-Study: * Eligible to receive adaptive components of ADEPT (vaccine-hesitant after provider recommendation) * At least 18 years of age * Provide informed consent * Agree to participate in surveys and in-depth interview * Agree for child's vaccination outcomes to be extracted from the North Carolina Immunization Registry (NCIR) * Plan to stay in North Carolina for at least 3 months after delivery Exclusion Criteria: * none

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of children receiving timely vaccinations

Timeframe: 2 months post birth

Trial details

NCT IDNCT05795855

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

View on ClinicalTrials.gov More Vaccination Refusal trials

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.