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

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.

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

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.

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Tracy Manuck, MD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2028-08-31

Completion

2029-01-31

Countries

• United States

Study Locations