Trials / Not Yet Recruiting

Not Yet RecruitingNCT06915428

Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities

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

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 1,228 (estimated)

Sponsor: University of North Carolina, Chapel Hill · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

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 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.

Detailed description

This project addresses the major public health problem of preterm birth (PTB), delivery \<37 weeks, by deploying a novel, personalized, comprehensive 3-tier PTB prevention program \[University of North Carolina (UNC) PTBCARE+\]. PTB affects 1 in 10 infants born in the United States (US) and is the leading cause of neonatal morbidity and mortality; survivors are at high risk for lifelong adverse health sequelae. Stress is an established risk factor for both spontaneous PTB (sPTB) and medically indicated PTB miPTB). Of significant public health concern, Black patients have 49% higher rates of PTB, are more likely to have early PTB, and increased perceived stress in pregnancy compared to patients of other races. Stress may alter biology, including stress-related gene expression in maternal blood and allostatic load index. Evidence from other fields of medicine supports incorporation of both stress reduction programs and 'patient navigators' as effective approaches to improve health outcomes, and data in obstetrics supports improved outcomes with PTB specialty clinics. However, such programs are not routinely employed in obstetrics. The effect of a specialty prenatal care program targeting stress reduction as a strategy to reduce PTB and PTB disparities remains unknown, representing a critical knowledge gap. The central hypothesis of this project is that enrollment in a personalized, comprehensive PTB support program (UNC PTBCARE+) is associated with reduced perceived stress, stress-related gene expression, allostatic load, and lower rates of PTB \<35 weeks. This hypothesis is supported by published and preliminary data as follows: First, UNC pregnant patients at high risk for PTB have high rates of stress and life stressors (e.g., financial insecurity, racism). Second, biologic stress markers including gene transcript levels differ by PTB status in mid-pregnancy blood. Third, specialty PTB care reduces stress in a NC cohort. Building upon prior work and that of others, this exciting proposal evaluates the efficacy of the novel UNC PTBCARE+ program. The investigation focus on PTB \<35 weeks due to its relative frequency, higher association with neonatal morbidity and mortality as compared to later PTB, to include PTB in the 34th week of gestation (because the delivery gestational age considered 'standard of care' for delivery among individuals with stable but severe preeclampsia and preterm membrane rupture), and to align with multiple other published PTB RCTs. This study will recruit 1,350 pregnant patients between 8+0 and 19+6 weeks gestation with an elevated a priori risk of either medically-indicated preterm birth or spontaneous preterm birth. Subjects will be randomized 2:1 to receive UNC PTBCARE+ vs. usual care. Randomization will be stratified based on maternal race and ethnicity (individuals who identify only as White and non-Hispanic vs. individuals who identify as belonging to one or more other races and/or Hispanic ethnicity and (b) perceived stress scores (those with perceived stress scores ≥20 vs. those with lower perceived stress scores scores). All participants, regardless of randomization assignment, will have 2 study visits during pregnancy. * Visit 1 (V1) will occur at randomization, 8+0 - 19+6 weeks gestation. * Visit 2 (V2) will occur in mid pregnancy, between 22+0 and 29+6 weeks gestation. At both visits, patients will complete validated surveys evaluating a broad spectrum of stressors, discrimination, adverse childhood experiences, perceived social support, resiliency, medication barriers and adherence, care access and satisfaction,, intervention fidelity and sustainability, use of stress relief modalities, and have blood collected to measure biologic stress markers. The UNC PTBCARE+ program is personalized. All patients randomized to UNC PTBCARE+ receive a stress reduction toolkit and will work with a PTB Care Coordinator who will provide support, facilitate clinician-prescribed medical care, and serve as a patient-provider liaison. Additional benefits / support items and support elements are provided to some participants on an "as needed" basis, per study protocol, and are not included in the initial registration to preserve scientific integrity and protect the rights of research participants. This study registration will be updated with complete intervention details after the study is fully enrolled and all participants have delivered. Psychosocial and financial stressor screening results from V1 will determine UNC PTBCARE+ tier assignment. Thus, participants are randomized only after Visit 1 surveys are completed. This solutions-oriented RCT of UNC PTBCARE+ vs. usual care provides an ideal forum to test the primary hypothesis and study stress-related PTB pathophysiology through the following Aims: * Aim 1. Evaluate the effects of the UNC PTBCARE+ program on perceived stress and resilience in pregnant patients at high risk for PTB. Hypothesis: Patients randomized to UNC PTBCARE+ will have lower levels of perceived stress and higher levels of resilience at V2 vs. V1; those randomized to usual care will have no change. * Aim 2. Quantify the extent to which the UNC PTBCARE+ program is associated with improved biologic stress measures during pregnancy. Hypothesis: Patients randomized to UNC PTBCARE+ will have reduced stress-related gene expression and allostatic load scores in maternal blood at V2 vs. V1 compared to those randomized to usual care who will have no change, increasing insight into PTB pathophysiology. * Aim 3. Determine the effects of the UNC PTBCARE+ program on PTB \<35 weeks. Hypothesis: Patients randomized to UNC PTBCARE+ will have lower rates of early PTB compared to those randomized to usual care. This study provides tangible, personalized solutions to the major public health problem of PTB and carries enormous potential to provide generalizable, low-risk strategies to reduce PTB and related disparities.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Care coordination	Research team members will serve as research assistants and will also function as perinatal care coordinators. In the care coordination role, team members will provide emotional support, liaise with clinical staff, and execute regularly scheduled check-ins with each study participant. Team members also assist with helping participants with logistics, obtaining and remembering to take prescribed medications, and other similar related activities. Participants receive access to contact the research assistant / care coordinator by text, email, phone, or through the electronic medical record participant portal. \- Per protocol, the research staff will meet in person with participants at least twice (visit 1, visit 2) during pregnancy and once postpartum (0-10 weeks after delivery, for most participants). Research staff may also meet in person with participants prior to visit 1 for recruitment/enrollment purposes.
BEHAVIORAL	Electronic massage	Participant is given the option to receive a 15-minute electronic massage / relaxation session in clinic via (a) a specialized massage chair or (b) a massage pad that is placed on top of a standard recliner chair. * the electronic massages provide gentle massages and are safe for most people to use throughout pregnancy. * participants are always be in control of the massage experience and will be given instructions on how to stop the massage at any time. * participants are advised to consult the primary obstetric provider before using the massage chair regarding any specific concerns or questions * during the session, participants may view relaxation videos (from free, publicly available sites online). * participants may choose to sign up for massage(s) at any obstetric visit in the clinic between visit 1 and delivery.
BEHAVIORAL	support gift #1	* Small gift packet with encouraging items (example of items = coloring kit, tea lights, stickers, bookmarks, keychain fidget toy, printed support index cards, and other similar items). * Given between 14+0 and 23+6 weeks gestation at time of routine prenatal appointment
BEHAVIORAL	Support gift #2	* Small gift packet with encouraging items (example of items = coloring kit, tea lights, stickers, bookmarks, keychain fidget toy, printed support index cards, and other similar items). * Given between 18+0 and 27+6 weeks gestation at time of routine prenatal appointment
BEHAVIORAL	Support gift #3	* Small gift packet with encouraging items (example of items = coloring kit, tea lights, stickers, bookmarks, keychain fidget toy, printed support index cards, and other similar items). * Given between 22+0 and 29+6 weeks gestation at time of routine prenatal appointment
BEHAVIORAL	Support gift #4	* Small gift packet with encouraging items (example of items = coloring kit, tea lights, stickers, bookmarks, keychain fidget toy, printed support index cards, and other similar items). * Given between 26+0 and 33+6 weeks gestation at time of routine prenatal appointment
BEHAVIORAL	Additional PTBCARE+ support	Additional benefits / support items and support elements are provided to some participants on an "as needed" basis, per study protocol. * Information / details intentionally withheld and not made public in order to preserve the scientific validity of the study and protect the rights of the research participants * participant eligibility for additional resources as a part of the PTBCARE+ program will be determined by the research staff on the day of Visit 1 after initial set of surveys are completed, and is per protocol
BEHAVIORAL	Stress reduction toolkit - Visit 1 (V1)	In person check-in with research team member re: participant's needs; research team member provides support. Physical items that are included as part of this visit include: Tote bag with the following stress reduction items or similar: * eye mask * set of pocket index cards, printed back and front, on a variety of topics that influence pregnancy health, ranging from physical to emotional/mental * water bottles * small notebook * pill minder case * magnet and business card for Health Resources and Services Administration (HRSA) national maternal mental health hotline * log in codes for electronic resources * initial handouts with self care plan, introduction to stress reduction toolkit, etc.
BEHAVIORAL	PTBCARE+ mobile application (app) and website	Comprehensive, study-specific app that is available as a website or as a downloadable application that includes personalized, interactive modules and resources * no study related materials are available without a password * goal is to collate reputable sources of information to make investigating things online easier * includes optional educational modules for participants * also includes option of entering stress, well-being, blood sugar, blood pressure, etc. values with option to easily download recorded values for patient's clinical team * available online (computer/laptop), tablet, or smart phone. can be downloaded as a progressive web application (PWA) to a local device and used without internet access * Electronic access to the PTBCARE+ website will continue through 10 weeks postpartum unless the participant delivered \<16+0 weeks gestation in which case access will continue through 4 weeks postpartum
BEHAVIORAL	Sleep, meditation, and Wellness app	* complimentary one-year subscription to Aura - an 'all-in-one' wellbeing app that contains an enormous library of meditations, stories, breath work, work wellness, music, sounds, and more! * Participants can access this app as needed throughout pregnancy and beyond, for up to one year after the date of enrollment
BEHAVIORAL	Emergency low blood sugar kit	Pouch contains: * printed index card with information about signs and symptoms of low blood sugar * printed index card with information about what to do if blood sugar is low * 2-3 non-perishable, individually wrapped over the counter candy / glucose-raising options; use for low blood sugar treatment is described on the card Only participants who have a diagnosis of diabetes mellitus or glucose intolerance AND have been prescribed an oral medication for blood sugar control or have been prescribed insulin are eligible to receive this. Each participant can receive a maximum of two kits during pregnancy; first at enrollment, and the other at visit 2 or until delivery
BEHAVIORAL	Low dose aspirin (LDA)	* Bottle of 90-100 pills (depending on manufacturer) * Provided at Visit 1 (after randomization) * Patients who received a bottle of low-dose aspirin at Visit 1 are offered a 2nd bottle at Visit 2. All patients whose provider recommends or prescribes either 81mg or 162mg of LDA during pregnancy are offered LDA as described herein. LDA must be on the patient's med list or specific notes from the patient's prenatal provider must explicitly note that it is recommended the patient take LDA in pregnancy for it to be offered. Individuals who are receiving LDA due to participation in another study are not eligible to receive LDA from PTBCARE+ Please note that this is listed as a "behavioral" intervention rather than "drug" intervention because the rational behind providing this over the counter medication is to help make the participant's life easier, and the focus is not on the efficacy of LDA. As such, it is being provided as a behavioral intervention.
BEHAVIORAL	Visit #2 Stress Reduction Toolkit	In person check-in with research team member re: participant's needs; research team member provides support. Physical items that are included as part of this visit include the following stress reduction items or similar: 1. Frame + ultrasound photo + certificate of achievement! * Picture from anatomy ultrasound (or other subsequent ultrasound) is downloaded, printed, and placed in frame. * Certificate of achievement is printed and placed on other side of frame with ultrasound photo 2. other small items including stickers, printed index cards with supportive messaging, etc.

Timeline

Start date: 2026-02-01
Primary completion: 2028-08-01
Completion: 2029-01-01
First posted: 2025-04-08
Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06915428. Inclusion in this directory is not an endorsement.