Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
Public ClinicalTrials.gov record NCT06915428. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Personalized Toolkit Building a Comprehensive Approach to Resource Optimization and Empowerment in Pregnancy & Beyond (PTBCARE+) A Randomized Controlled Trial (RCT) of Personalized Care for Prenatal Stress Reduction and Preterm Birth Disparities Prevention
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 massage while in clinic, and more. * additional support gifts provided at routine clinical appointments People who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.
Study identification
- NCT ID
- NCT06915428
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,228 participants
Conditions and interventions
Conditions
- Preterm Birth Complication
- Preterm Birth
- Preterm Birth Recurrence
- Preeclampsia
- Preeclampsia (PE)
- Hypertensive Disorders of Pregnancy
- Support Program
- Stress
- Resilience, Psychological
- Empowerment, Patient
- Emotional Stress
- Pregnancy
- Pregnancy Complications
- Pregnancy Induced Hypertension
- Neonates and Preterm Infants
- Cervical Insufficiency
- Social Determinants of Health (SDOH)
- Cervical Shortening
- Disparities in Pregnancy Complications
- Disparities
- Prenatal Care
- Care Coordination
Interventions
- Care coordination Behavioral
- Electronic massage Behavioral
- support gift #1 Behavioral
- Support gift #2 Behavioral
- Support gift #3 Behavioral
- Support gift #4 Behavioral
- Additional PTBCARE+ support Behavioral
- Stress reduction toolkit - Visit 1 (V1) Behavioral
- PTBCARE+ mobile application (app) and website Behavioral
- Sleep, meditation, and Wellness app Behavioral
- Emergency low blood sugar kit Behavioral
- Low dose aspirin (LDA) Behavioral
- Visit #2 Stress Reduction Toolkit Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2026
- Primary completion
- Jul 31, 2028
- Completion
- Dec 31, 2028
- Last update posted
- Jun 28, 2026
2026 – 2029
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of North Carolina School of Medicine - Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06915428, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 28, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06915428 live on ClinicalTrials.gov.