Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities

Starting soon · Not applicable

Conditions studied: Preterm Birth Complication, Preterm Birth, Preterm Birth Recurrence, Preeclampsia, Preeclampsia (PE), Hypertensive Disorders of Pregnancy, Support Program, Stress, Resilience, Psychological, Empowerment, Patient, Emotional Stress, Pregnancy, Pregnancy Complications, Pregnancy Induced Hypertension, Neonates and Preterm Infants, Cervical Insufficiency, Social Determinants of Health (SDOH), Cervical Shortening, Disparities in Pregnancy Complications, Disparities, Prenatal Care, Care Coordination

In brief

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.

Key facts

Study ID

NCT06915428

Run by

University of North Carolina, Chapel Hill

People needed

1228

Starts

2026-08-01

Expected to finish

2029-01-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Gestational age at first ultrasound by last menstrual period (LMP) / Ultrasound method / Measurement agreement with LMP required • Up to 8 weeks 6 days / crown rump length / ± 5 days
• 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
• Gestational dating / fetal viability must be confirmed by ultrasound prior to enrollment / randomization.
• Ultrasound report must include documentation of normal fetal heart rate of ≥ 120 beats per minute, or subsequent medical record documentation of auscultation of fetal heart rate ≥ 120 beats per minute.
• Viability must be confirmed / re-confirmed within 7 days of randomization.
• If initial consent occurs early in pregnancy and V1/randomization occur later, viability must be reconfirmed to ensure ongoing eligibility prior to initiating V1 activities (including surveys) and proceeding with randomization.
• No signs or symptoms of, or clinical diagnosis of, evolving miscarriage, active preterm labor, preterm prelabor rupture of membranes at the time of enrollment.
• Cervical dilation at the time of enrollment is an exclusion criterion. However, cervical evaluation and digital cervical exam is not required prior to enrollment.
• (3a) High a priori risk for medically indicated preterm birth - must meet at least one of the following 3 criteria (maternal medical history, prior pregnancy history, or moderate risk factor history)
• miPTB criteria #1: Maternal Medical History - any one of the following:
• o Known chronic hypertension requiring medications in the 3 months prior to conception or prior to 22 weeks gestation.
• o At least 2 blood pressure readings 6 hours apart, <20 weeks gestation, with systolic ≥ 130 mmHg or diastolic ≥ 80 mmHg *regardless of need for medication or formal diagnosis of hypertension in chart*
• o Pre-gestational diabetes mellitus.
• Diabetes diagnosed <20 weeks gestation.
• Maternal chronic or sub-acute renal disease, including chronic kidney failure, chronic renal insufficiency, glomerulonephritis, lupus nephritis, defined as any:
• biopsy proven chronic renal disease history; and/or
• serum creatinine ≥ 1.1 mg/dL at any time during pregnancy prior to enrollment, in the absence of other identifiable transient factors per clinician's assessment (e.g., extreme dehydration, cystitis, pyelonephritis); and/or
• chronic proteinuria, defined as baseline urine protein:creatinine ratio ≥ 0.30 mg/dL or 24 hour total urine protein ≥ 300 mg in the absence of other identifiable transient factors per clinician's assessment (e.g., extreme dehydration, cystitis, pyelonephritis)
• Systemic Lupus Erythematosus
• Antiphospholipid Antibody Syndrome
• miPTB criteria #2: Prior pregnancy history - any ONE of the following: o Previous pregnancy complicated by preeclampsia or hypertensive disorders of pregnancy at any gestational age, in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.
• o Previous history of stillbirth ≥ 16+0 weeks in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy. The stillbirth etiology must not have been attributed to physical trauma (e.g., domestic violence, motor vehicle accident) or illicit drug use (e.g., cocaine use leading to abruption and stillbirth).

You may not qualify if…

• 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.
• o There are some concurrent studies, even those designed to test an intervention, which may be compatible with the current study; this will be reviewed by the investigative leadership team on a case-by-case basis.
• 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.
• Receiving treatment for opioid use disorder with methadone, suboxone, or similar in an approved treatment program is not an exclusion.
• History of radical trachelectomy
• Planned voluntary termination of pregnancy.
• Heavy vaginal bleeding or large subchorionic hemorrhage - defined as:
• Bleeding as primary reason for unplanned clinic evaluation or emergency room visit within 14 days of potential enrollment
• Subjective bleeding accompanied by ≥ 4 point drop in the hematocrit within 14 days of potential enrollment
• Subchorionic hemorrhage or abruption on formal ultrasound with a volume ≥ 64 cubic cm (4cm x 4cm x 4cm) within 14 days of potential enrollment
• Major congenital anomaly such as major structural deficit of the heart, lungs, brain, or other major organ system
• Mild renal abnormalities, clubfoot, isolated cleft lip/palate, etc. in the fetus are not a reason for exclusion.
• Isolated 'soft markers' for aneuploidy (such as choroid plexus cysts, echogenic bowel, etc.) are not a reason for exclusion.
• If a major congenital anomaly is diagnosed *after* enrollment, the patient will continue to participate in the study, however, the investigators will plan to analyze the study results with and without these individuals included.
• Positive aneuploidy screening test (traditional biochemical assay, e.g., quad screen - risk of aneuploidy of 1:25 or higher or cell free deoxynucleic acid (DNA) test result that is screen positive for trisomy 13, trisomy 18, trisomy 21, or sex chromosome abnormality) in the absence of definitive fetal karyotype evaluation.
• Definitive fetal karyotype evaluation can only be obtained through direct testing of the tissue from the conceptus - by chorionic villus sampling or amniocentesis during pregnancy.
• The term "suspected aneuploidy" is commonly used in the medical record but this is not a diagnosis and by itself is not informative and not an exclusion criteria.
• Cystic hygroma or abnormally thickened nuchal translucency ≥ 3 mm at any time in the current gestation, regardless of subsequent diagnostic testing results.
• Note that a cystic hygroma remains an exclusion criterion regardless of subsequent diagnostic testing results because fetuses with this history carry an elevated risk of major congenital heart disease.
• Fetal echocardiogram is most accurately performed at 22-24 weeks gestation, which is later than the enrollment gestational age window.
• Polyhydramnios at or prior to enrollment.
• o Polyhydramnios is defined as a maximum vertical pocket ≥ 8.0 cm, given that polyhydramnios <22 weeks has a high likelihood of being associated with congenital anomalies/aneuploidy and/or preterm birth due to preterm prelabor rupture of membranes.
• For potential participants who meet eligibility criteria ONLY due to prior spontaneous or medically indicated preterm birth: if the prior preterm birth was in a pregnancy complicated by twins, confirmed fetal aneuploidy, or major congenital fetal anomalies in the absence of another pregnancy meeting inclusion criteria they are not eligible.

Where it is running

• University of North Carolina School of Medicine - Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.