About 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.

Eligibility criteria

Qualifiers

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.

9 weeks 0 days to 13 weeks 6 days / crown rump length / ± 7 days

14 weeks 0 days to 15 weeks 6 days / standard fetal biometry / ± 7 days

16 weeks 0 days to 19 weeks 6 days / standard fetal biometry / ± 10 days

Disqualifiers

Participation in another intervention based clinical trial during pregnancy that is deemed, at the discretion of the investigative team for the current study or the other concurrent study, to conflict with this research and/or confound the study results.

Previous participation in the PTBCARE+ program in another pregnancy, with randomization to the PTBCARE+ (active intervention) group.

Current, ongoing, illicit drug use ≥ 12 weeks gestation.

Use of tobacco and/or marijuana products is not an exclusion.

Trial design

Treatments tested in this trial

  • Care coordination
  • Electronic massage
  • support gift #1
  • Support gift #2
  • Support gift #3
  • Support gift #4
  • Additional PTBCARE+ support
  • Stress reduction toolkit - Visit 1 (V1)
  • PTBCARE+ mobile application (app) and website
  • Sleep, meditation, and Wellness app
  • Emergency low blood sugar kit
  • Low dose aspirin (LDA)
  • Visit #2 Stress Reduction Toolkit

Treatment groups

1,228 Participants
are divided into 2 treatment groups

Locations

1
University of North Carolina School of Medicine - Chapel Hill27599, Chapel HillNorth Carolina, United States

Sponsors and collaborators

University of North Carolina, Chapel Hill

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator