Prenatal Support Program for Premature Birth

(PTBCARE+ Trial)

Overseen By Amber Ivins

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Illicit drug use, Radical trachelectomy, Major congenital anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a personalized prenatal support program, called Personalized Toolkit Building a Comprehensive Approach to Resource Optimization and Empowerment in Pregnancy & Beyond (PTBCARE+), can reduce stress and lower the risk of premature birth for individuals at high risk of early delivery. Researchers aim to determine if the program can decrease self-reported stress, improve biological stress markers, and increase the likelihood of delivering a healthy, full-term baby. Participants will either receive this special support program or continue with usual prenatal care. Pregnant individuals with a single baby and a history of preterm birth, high blood pressure, or other specific health conditions may be suitable for the study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance prenatal care for high-risk pregnancies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial team or your healthcare provider.

What prior data suggests that the PTBCARE+ support program is safe for pregnant individuals?

Research has shown that personalized support programs like PTBCARE+ are usually safe and well-received. This program provides extra help and resources to pregnant individuals, aiming to lower stress and improve pregnancy outcomes. Although specific safety data for PTBCARE+ is not available, similar programs have not raised major safety concerns in past studies. The program enhances care without introducing new medical procedures or drugs, often resulting in fewer risks. Participants can generally expect the program to be safe, as it primarily involves additional support and resources. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PTBCARE+ program because it offers a personalized, comprehensive support system for pregnant individuals at high risk for preterm birth. Unlike standard prenatal care, which typically involves regular check-ups and basic resource sharing, PTBCARE+ provides a tailored toolkit designed to optimize resources and empower patients throughout pregnancy. This program enhances the prenatal care experience by integrating extensive support resources, potentially leading to better outcomes for both mothers and their babies.

What evidence suggests that the PTBCARE+ support program is effective for reducing stress and lowering the risk of preterm birth?

Research shows that high stress levels during pregnancy can increase the risk of preterm birth. In this trial, participants may receive the PTBCARE+ support program, which studies have found can help reduce stress and improve outcomes for pregnant individuals. PTBCARE+ offers tools to manage stress, including a relaxation kit and online resources. Early results suggest that lowering stress can lead to better heart rate variability, indicating less stress and healthier pregnancy outcomes. This program aims to help pregnant individuals by providing resources that may assist them in carrying their pregnancy closer to full term. ^{1 2 3 6 7}

Who Is on the Research Team?

Tracy Manuck, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Initial Assessment

Participants are randomized to either the PTBCARE+ program or usual care and complete initial assessments.

Up to 11 weeks

1 visit (in-person)

Mid-Pregnancy Follow-up

Participants complete a follow-up visit to assess stress levels and other health metrics.

Up to 7 weeks

1 visit (in-person)

Postpartum Follow-up

Participants are monitored for postpartum outcomes and complete final assessments.

10 weeks

1 visit (in-person, optional activities)

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

This review analyzed maternal risks associated with pregnancy and childbirth, focusing on both short- and long-term outcomes, using data from large cohort studies involving 54,000 births to create an educational tool for better understanding maternal morbidity and mortality.

Key risk factors for increased maternal morbidity include advanced maternal age (over 45 years), pre-existing health conditions like hypertension or cardiac issues, and complications during pregnancy such as gestational hypertension and postpartum hemorrhage, highlighting the need for personalized pre-conception education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Real Maternal Risks in a Pregnancy: A Structured Review to Enhance Maternal Understanding and Education. Wilson, RD.[2021]

Financial support significantly increased maternal engagement in caregiving activities, with mothers receiving financial assistance being 85% more likely to provide skin-to-skin care and 36% more likely to provide breastmilk for their preterm infants in the NICU.

The study involved 46 Medicaid-eligible mothers and observed their behaviors over 703 days, but while financial support improved caregiving, it did not show a significant impact on neonatal growth or length of stay in the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial Support to Medicaid-Eligible Mothers Increases Caregiving for Preterm Infants. Andrews, KG., Martin, MW., Shenberger, E., et al.[2020]

A total of 355 adverse events and near misses in newborns were reported to Brazil's NOTIVISA system from 2007 to 2013, with the majority (65.6%) related to medications, particularly silver nitrate and antibiotics.

The most common adverse event associated with medical devices was phlebitis from IV lines, highlighting the need for improved safety measures and reporting systems in neonatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neonatal adverse events and near misses reported in Brazil from 2007 to 2013]. Lanzillotti, Lda S., Andrade, CL., Mendes, W., et al.[2017]

In a study of 15,330 pregnant women across 13 healthcare practices in South Carolina, group prenatal care significantly reduced the rates of preterm births by 3.2%, low birth weight by 3.7%, and NICU admissions by 4.0% compared to usual individual prenatal care.

The findings suggest that CenteringPregnancy group prenatal care is an effective and feasible model for improving maternal and infant health outcomes, making it a valuable option for other Perinatal Quality Collaboratives to implement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Multi-site Expansion of Group Prenatal Care on Birth Outcomes. Crockett, AH., Heberlein, EC., Smith, JC., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-toxemia-7-2025-63b2a

Prenatal Support Program for Premature Birth (PTBCARE+ ... Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy & Beyond (PTBCARE+). Trial Overview The PTBCARE+ ...

2. ajpmonline.org ajpmonline.org/article/S0749-3797(24)00310-6/fulltext

Providing Quality Family Planning Services in the United ... These recommendations outline how to provide people of reproductive age with high-quality SRH services, including family-building services, ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK513805/

Evidence and recommendations - NCBI - NIH Provision of respectful maternity care (RMC) is in accordance with a human rights-based approach to reducing maternal morbidity and mortality. RMC could improve ...

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1002/ijgo.70503?af=R

Poster Presentations - 2025 - Obstetrics and Gynecology - Wiley Primary outcome measures were preterm labor, premature ... Method: Data on the China Birth Cohort Study (CBCS), nationwide pregnancy ...

5. hhs.gov hhs.gov/sites/default/files/fy2025-performance-plan.pdf

U.S. Department of Health and Human Services FY 2025 ... ... pregnancy or birth during the first trimester can also help improve birth outcomes. HRSA set the FY 2025 target based on data trends. HRSA will continue to ...

6. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1002/ijgo.70503

Poster Presentations - 2025 - Obstetrics and Gynecology - Wiley Method: For this scoping review, 6 databases were searched using the PCC framework (Problem: Spontaneous preterm birth; Concept: nutrition; ...

7. federalregister.gov federalregister.gov/documents/2024/01/09/2023-28857/health-data-technology-and-interoperability-certification-program-updates-algorithm-transparency-and

Health Data, Technology, and Interoperability: Certification ... In this final rule we apply the concept of health equity by design to bring transparency to the quality and performance of intelligence and ...