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

1228 Participants Needed

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.

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 data supports the effectiveness of the treatment PTBCARE+ for preventing premature birth?

The PretermConnect app, which is similar to PTBCARE+, has shown promise in empowering women at risk for preterm birth by providing education and support, potentially preventing recurrent preterm births and reducing infant mortality rates. ^{1 2 3 4 5}

Is the Prenatal Support Program for Premature Birth safe for humans?

The research on group prenatal care, which is similar to the Prenatal Support Program, shows it is generally safe and can improve birth outcomes like reducing preterm births and low birth weight. No specific safety concerns were reported in the studies reviewed. ^{1 4 6 7 8}

How is the PTBCARE+ treatment different from other treatments for preventing premature birth?

PTBCARE+ is unique because it focuses on building a personalized toolkit to optimize resources and empower pregnant women, which is not a standard approach in existing treatments for preventing premature birth. This comprehensive strategy may include elements like financial support and social support, which are not typically emphasized in traditional prenatal care programs. ^{2 9 10 11 12}

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.

Timeline

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)

Treatment Details

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.

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators to Recurrent Preterm Birth Prevention among Low-Income Women: A Qualitative Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Prevention of recurrent preterm birth: role of the neonatal follow-up program. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Preterm Infants: Shifting Focus, Extending the View. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

PretermConnect: Leveraging mobile technology to mitigate social disadvantage in the NICU and beyond. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Development of Nationwide Recommendations to Support Prenatal Counseling in Extreme Prematurity. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of a Multi-site Expansion of Group Prenatal Care on Birth Outcomes. [2020]

7. Brazil pubmed.ncbi.nlm.nih.gov

[Neonatal adverse events and near misses reported in Brazil from 2007 to 2013]. [2017]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Financial Support to Medicaid-Eligible Mothers Increases Caregiving for Preterm Infants. [2020]

10. India pubmed.ncbi.nlm.nih.gov

The Effectiveness of Prenatal Care Programs on Reducing Preterm Birth in Socioeconomically Disadvantaged Women: A Systematic Review and Meta-Analysis. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Poverty as context for the parenting experience of low-income Lumbee Indian mothers with a medically fragile infant. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Maternal Characteristics Associated With Social Support in At-Risk Mothers of Premature Infants. [2022]