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NCT06915428 · ClinicalTrials.gov registry record · NA
Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Not yet
- Registry status
- NA
- Development phase
- 1,228
- Enrollment target
NCT06915428: Clinical Trial NA study, sponsored by University of North Carolina, Chapel Hill.
NCT06915428 is a NA study that has not yet begun recruiting, run by University of North Carolina, Chapel Hill. The registered enrollment target is 1,228 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06915428, a NA study, has not yet begun recruiting, sponsored by University of North Carolina, Chapel Hill.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 1,228 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if a personalized prenatal support program \[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\[s\] it aims to answer are: * Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy? * Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy? * Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term? Researchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term. Participants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care. All participants will be asked to: * complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device. * complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit. People who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as: * a stress reduction toolkit; * access to an online website that can also be downloaded as a smart phone app; * the option to receive an electronic massa
Primary Outcome
Perceived Stress Scale participant survey * Scores range 0-40 * Higher scores = higher stress
Interventions
- BEHAVIORAL Care coordination
- BEHAVIORAL Electronic massage
- BEHAVIORAL support gift #1
- BEHAVIORAL Support gift #2
- BEHAVIORAL Support gift #3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,228 participants |
| Start Date | 2026-08-01 |
| Est. Completion | 2029-01 |
| Phase | NA |
What is known before NCT06915428 opens enrollment
NCT06915428 is an interventional study that assigns participants to a tested intervention. Its 1,228 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 5 interventions - of which Care coordination is the first listed.
NCT06915428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06915428 about?
NCT06915428 is a clinical study titled "Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities". The goal of this clinical trial is to learn if a personalized prenatal support program \[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)\] works to lower stress and lower the risk of early delivery in pregnant indivi...
What is the current status of trial NCT06915428?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 1,228 participants. The study started on 2026-08-01. Estimated completion is 2029-01.
What interventions are being tested in trial NCT06915428?
The interventions under investigation include: Care coordination (BEHAVIORAL), Electronic massage (BEHAVIORAL), support gift #1 (BEHAVIORAL), Support gift #2 (BEHAVIORAL), Support gift #3 (BEHAVIORAL).
Who is sponsoring clinical trial NCT06915428?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06915428's enrollment target sits among peer trials
1,228 83rd of 2000 higher than 1,918 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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