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.
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Self-reported Perceived Stress Scores
Timeframe: Baseline (Visit 1 - 8+0 to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
Self-reported resilience scores
Timeframe: Baseline (Visit 1 - 8+0 to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
Maternal blood-based stress-related gene transcript levels
Timeframe: Baseline (Visit 1 - 8+0 to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
Number of participants with preterm birth or fetal death at 14 weeks 0 days or greater and less than 35 weeks gestation
Timeframe: Between 14 weeks 0 days and 35 weeks 0 days gestation (delivery at 34 weeks 6 days gestation meets the primary outcome; delivery at 35 weeks 0 days gestation does not) , a period of up to 27 weeks from enrollment.