Prenatal Support Program for Premature Birth

(PTBCARE+ Trial)

Overseen by Tracy Manuck, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of North Carolina, Chapel Hill

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Tracy Manuck, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for pregnant individuals at high risk of preterm birth. They must be willing to attend study visits, complete surveys, and provide blood and urine samples. Those with certain medical conditions or on specific medications that could affect the study's outcomes may not be eligible.

Inclusion Criteria

Ability to provide written, informed consent in English or Spanish

Planned prenatal care at the University of North Carolina at Chapel Hill obstetrics clinics and planned delivery at the University of North Carolina Women's Hospital (Chapel Hill, NC)

Viable, singleton pregnancy, 8+0 to 19+6 weeks, dated by last menstrual period ± ultrasound using standard obstetric criteria per American College of Obstetricians and Gynecologists

Exclusion Criteria

Planned voluntary termination of pregnancy

I have had heavy vaginal bleeding or a significant bleeding episode in the last 14 days.

I am not willing to be randomly assigned to a treatment group.

Treatment Details

Interventions

• Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy & Beyond (PTBCARE+) (Behavioural Intervention)

Trial Overview The PTBCARE+ program aims to reduce stress and prevent early delivery in high-risk pregnancies. It includes a personalized support toolkit, access to an app/website, electronic massage options, and gifts during routine appointments. The effectiveness will be compared against usual prenatal care.

Participant Groups

Group I: Personalized Toolkit Building a Comprehensive Approach to Resource (PTBCARE+) Support Program Active Control 13 Interventions

The UNC Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond (PTBCARE+) program is a multifaceted, personalized support program designed to help pregnant people at high risk for preterm birth. It enhances the prenatal care experience by adding extensive support resources.

Group II: Usual Prenatal Care Active Control 1 Intervention

Participants who are randomized to receive usual care will not receive the PTBCARE+ program. Research team members may contact participants only to remind them of study activities, and will conduct standard in-person follow-up visits per study protocol, but will not provide any additional information or support. Usual care participants will receive standardized resources offered to all prenatal patients in clinic per clinical provider discretion.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+