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NCT06915428
Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
Conditions: 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
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1228
Sponsor: University of North Carolina, Chapel Hill
Location: University of North Carolina School of Medicine - Chapel Hill Chapel Hill North Carolina
Summary
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
Inclusion Criteria:
1. 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.
2. 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, \ 2763g 6 lbs 1.5 oz \> 2379g 5 lbs 3.9 oz 35 weeks \> 3084g 6 lbs 12.8 oz \> 2661g 5 lbs 13.9 oz
* Documented history of a prior pregnancy complicated by asymptomatic cervical shortening \
Source: ClinicalTrials.gov (NCT06915428). StuddyBuddy aggregates publicly available trial information.