[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586442":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":103,"centralContacts":107,"locations":117,"responsibleParty":131,"collaborators":133,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":38,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":30,"enrollmentInfo":146,"targetDuration":30,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":176,"overallStatus":180,"whyStopped":30,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Personalized Toolkit Building a Comprehensive Approach to Resource (PTBCARE+) Support Program","ACTIVE_COMPARATOR","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.",[13,14,15,16,17,18,19,20,21,22,23,24,25],"Behavioral: Care coordination","Behavioral: Electronic massage","Behavioral: support gift #1","Behavioral: Support gift #2","Behavioral: Support gift #3","Behavioral: Support gift #4","Behavioral: Additional PTBCARE+ support","Behavioral: Stress reduction toolkit - Visit 1 (V1)","Behavioral: PTBCARE+ mobile application (app) and website","Behavioral: Sleep, meditation, and Wellness app","Behavioral: Emergency low blood sugar kit","Behavioral: Low dose aspirin (LDA)","Behavioral: Visit #2 Stress Reduction Toolkit",{"label":27,"type":28,"description":29,"interventionNames":30},"Usual Prenatal Care","NO_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.",null,[32,39,46,52,58,64,68,72,78,85,89,93,97],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BEHAVIORAL","Care coordination","Research team members will serve as research assistants and will also function as perinatal care coordinators.\n\nIn the care coordination role, team members will provide emotional support, liaise with clinical staff, and execute regularly scheduled check-ins with each study participant. Team members also assist with helping participants with logistics, obtaining and remembering to take prescribed medications, and other similar related activities. Participants receive access to contact the research assistant \u002F care coordinator by text, email, phone, or through the electronic medical record participant portal.\n\n\\- Per protocol, the research staff will meet in person with participants at least twice (visit 1, visit 2) during pregnancy and once postpartum (0-10 weeks after delivery, for most participants).\n\nResearch staff may also meet in person with participants prior to visit 1 for recruitment\u002Fenrollment purposes.",[9],[38],"PTBCARE+",{"type":33,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Electronic massage","Participant is given the option to receive a 15-minute electronic massage \u002F relaxation session in clinic via (a) a specialized massage chair or (b) a massage pad that is placed on top of a standard recliner chair.\n\n* the electronic massages provide gentle massages and are safe for most people to use throughout pregnancy.\n* participants are always be in control of the massage experience and will be given instructions on how to stop the massage at any time.\n* participants are advised to consult the primary obstetric provider before using the massage chair regarding any specific concerns or questions\n* during the session, participants may view relaxation videos (from free, publicly available sites online).\n\n  * participants may choose to sign up for massage(s) at any obstetric visit in the clinic between visit 1 and delivery.",[9],[44,45],"Massage chair","Relaxation session",{"type":33,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"support gift #1","* Small gift packet with encouraging items (example of items = coloring kit, tea lights, stickers, bookmarks, keychain fidget toy, printed support index cards, and other similar items).\n* Given between 14+0 and 23+6 weeks gestation at time of routine prenatal appointment",[9],[51],"cool calm and collected support gift",{"type":33,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"Support gift #2","* Small gift packet with encouraging items (example of items = coloring kit, tea lights, stickers, bookmarks, keychain fidget toy, printed support index cards, and other similar items).\n* Given between 18+0 and 27+6 weeks gestation at time of routine prenatal appointment",[9],[57],"Keep moving forward support gift",{"type":33,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Support gift #3","* Small gift packet with encouraging items (example of items = coloring kit, tea lights, stickers, bookmarks, keychain fidget toy, printed support index cards, and other similar items).\n* Given between 22+0 and 29+6 weeks gestation at time of routine prenatal appointment",[9],[63],"Small acts, big impact: pass it on",{"type":33,"name":65,"description":66,"armGroupLabels":67,"otherNames":30},"Support gift #4","* Small gift packet with encouraging items (example of items = coloring kit, tea lights, stickers, bookmarks, keychain fidget toy, printed support index cards, and other similar items).\n* Given between 26+0 and 33+6 weeks gestation at time of routine prenatal appointment",[9],{"type":33,"name":69,"description":70,"armGroupLabels":71,"otherNames":30},"Additional PTBCARE+ support","Additional benefits \u002F support items and support elements are provided to some participants on an \"as needed\" basis, per study protocol.\n\n* Information \u002F details intentionally withheld and not made public in order to preserve the scientific validity of the study and protect the rights of the research participants\n* participant eligibility for additional resources as a part of the PTBCARE+ program will be determined by the research staff on the day of Visit 1 after initial set of surveys are completed, and is per protocol",[9],{"type":33,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"Stress reduction toolkit - Visit 1 (V1)","In person check-in with research team member re: participant's needs; research team member provides support.\n\nPhysical items that are included as part of this visit include:\n\nTote bag with the following stress reduction items or similar:\n\n* eye mask\n* set of pocket index cards, printed back and front, on a variety of topics that influence pregnancy health, ranging from physical to emotional\u002Fmental\n* water bottles\n* small notebook\n* pill minder case\n* magnet and business card for Health Resources and Services Administration (HRSA) national maternal mental health hotline\n* log in codes for electronic resources\n* initial handouts with self care plan, introduction to stress reduction toolkit, etc.",[9],[77],"V1 Stress toolkit",{"type":33,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"PTBCARE+ mobile application (app) and website","Comprehensive, study-specific app that is available as a website or as a downloadable application that includes personalized, interactive modules and resources\n\n* no study related materials are available without a password\n* goal is to collate reputable sources of information to make investigating things online easier\n* includes optional educational modules for participants\n* also includes option of entering stress, well-being, blood sugar, blood pressure, etc. values with option to easily download recorded values for patient's clinical team\n* available online (computer\u002Flaptop), tablet, or smart phone. can be downloaded as a progressive web application (PWA) to a local device and used without internet access\n* Electronic access to the PTBCARE+ website will continue through 10 weeks postpartum unless the participant delivered \\\u003C16+0 weeks gestation in which case access will continue through 4 weeks postpartum",[9],[83,84],"PTBCARE+ website","PTBCARE+ app",{"type":33,"name":86,"description":87,"armGroupLabels":88,"otherNames":30},"Sleep, meditation, and Wellness app","* complimentary one-year subscription to Aura - an 'all-in-one' wellbeing app that contains an enormous library of meditations, stories, breath work, work wellness, music, sounds, and more!\n* Participants can access this app as needed throughout pregnancy and beyond, for up to one year after the date of enrollment",[9],{"type":33,"name":90,"description":91,"armGroupLabels":92,"otherNames":30},"Emergency low blood sugar kit","Pouch contains:\n\n* printed index card with information about signs and symptoms of low blood sugar\n* printed index card with information about what to do if blood sugar is low\n* 2-3 non-perishable, individually wrapped over the counter candy \u002F glucose-raising options; use for low blood sugar treatment is described on the card\n\nOnly participants who have a diagnosis of diabetes mellitus or glucose intolerance AND have been prescribed an oral medication for blood sugar control or have been prescribed insulin are eligible to receive this.\n\nEach participant can receive a maximum of two kits during pregnancy; first at enrollment, and the other at visit 2 or until delivery",[9],{"type":33,"name":94,"description":95,"armGroupLabels":96,"otherNames":30},"Low dose aspirin (LDA)","* Bottle of 90-100 pills (depending on manufacturer)\n* Provided at Visit 1 (after randomization)\n* Patients who received a bottle of low-dose aspirin at Visit 1 are offered a 2nd bottle at Visit 2.\n\nAll patients whose provider recommends or prescribes either 81mg or 162mg of LDA during pregnancy are offered LDA as described herein. LDA must be on the patient's med list or specific notes from the patient's prenatal provider must explicitly note that it is recommended the patient take LDA in pregnancy for it to be offered. Individuals who are receiving LDA due to participation in another study are not eligible to receive LDA from PTBCARE+\n\nPlease note that this is listed as a \"behavioral\" intervention rather than \"drug\" intervention because the rational behind providing this over the counter medication is to help make the participant's life easier, and the focus is not on the efficacy of LDA. As such, it is being provided as a behavioral intervention.",[9],{"type":33,"name":98,"description":99,"armGroupLabels":100,"otherNames":101},"Visit #2 Stress Reduction Toolkit","In person check-in with research team member re: participant's needs; research team member provides support.\n\nPhysical items that are included as part of this visit include the following stress reduction items or similar:\n\n1. Frame + ultrasound photo + certificate of achievement!\n\n   * Picture from anatomy ultrasound (or other subsequent ultrasound) is downloaded, printed, and placed in frame.\n   * Certificate of achievement is printed and placed on other side of frame with ultrasound photo\n2. other small items including stickers, printed index cards with supportive messaging, etc.",[9],[102],"Celebrate Today, Believe in Tomorrow",[104],{"name":105,"affiliation":5,"role":106},"Tracy Manuck, MD","PRINCIPAL_INVESTIGATOR",[108,113],{"name":109,"role":110,"phone":111,"phoneExt":30,"email":112},"Tracy A Manuck, MD, MSCI","CONTACT","8015998164","tmanuck@med.unc.edu",{"name":114,"role":110,"phone":115,"phoneExt":30,"email":116},"Amber Ivins","9199661601","amber_ivins@med.unc.edu",[118],{"facility":119,"status":30,"city":120,"state":121,"zip":122,"country":123,"countryCode":124,"cosmosGeoPoint":125,"geoPoint":130,"contacts":30},"University of North Carolina School of Medicine - Chapel Hill","Chapel Hill","North Carolina","27599","United States","US",{"type":126,"coordinates":127},"Point",[128,129],-79.05584,35.9132,{"lat":129,"lon":128},{"type":132,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[134],{"name":135,"class":136},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH","100586442","personalized-care-for-prenatal-stress-reduction--prevention-of-preterm-birth-ptb-disparities-100586442",false,"NCT06915428","Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities","Personalized Toolkit Building a Comprehensive Approach to Resource Optimization and Empowerment in Pregnancy & Beyond (PTBCARE+) A Randomized Controlled Trial (RCT) of Personalized Care for Prenatal Stress Reduction and Preterm Birth Disparities Prevention","Inclusion Criteria:\n\n1. 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.\n\n   Gestational age at first ultrasound by last menstrual period (LMP) \u002F Ultrasound method \u002F Measurement agreement with LMP required • Up to 8 weeks 6 days \u002F crown rump length \u002F ± 5 days\n   * 9 weeks 0 days to 13 weeks 6 days \u002F crown rump length \u002F ± 7 days\n   * 14 weeks 0 days to 15 weeks 6 days \u002F standard fetal biometry \u002F ± 7 days\n   * 16 weeks 0 days to 19 weeks 6 days \u002F standard fetal biometry \u002F ± 10 days\n   * Gestational dating \u002F fetal viability must be confirmed by ultrasound prior to enrollment \u002F randomization.\n   * 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.\n   * Viability must be confirmed \u002F re-confirmed within 7 days of randomization.\n\n   If initial consent occurs early in pregnancy and V1\u002Frandomization occur later, viability must be reconfirmed to ensure ongoing eligibility prior to initiating V1 activities (including surveys) and proceeding with randomization.\n2. No signs or symptoms of, or clinical diagnosis of, evolving miscarriage, active preterm labor, preterm prelabor rupture of membranes at the time of enrollment.\n\n   * Cervical dilation at the time of enrollment is an exclusion criterion. However, cervical evaluation and digital cervical exam is not required prior to enrollment.\n\n     (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)\n   * miPTB criteria #1: Maternal Medical History - any one of the following:\n\n     o Known chronic hypertension requiring medications in the 3 months prior to conception or prior to 22 weeks gestation.\n\n     o At least 2 blood pressure readings 6 hours apart, \\\u003C20 weeks gestation, with systolic ≥ 130 mmHg or diastolic ≥ 80 mmHg \\*regardless of need for medication or formal diagnosis of hypertension in chart\\*\n\n     o Pre-gestational diabetes mellitus.\n     * Diabetes diagnosed \\\u003C20 weeks gestation.\n     * Maternal chronic or sub-acute renal disease, including chronic kidney failure, chronic renal insufficiency, glomerulonephritis, lupus nephritis, defined as any:\n\n       \\*biopsy proven chronic renal disease history; and\u002For\n\n       \\*serum creatinine ≥ 1.1 mg\u002FdL 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\u002For\n\n       \\*chronic proteinuria, defined as baseline urine protein:creatinine ratio ≥ 0.30 mg\u002FdL 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)\n\n       \\*Systemic Lupus Erythematosus\n       * Antiphospholipid Antibody Syndrome\n   * 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.\n\n     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).\n   * miPTB criteria #3: Any two or more of the following moderate risk factors: o Nulliparity, defined as no prior pregnancy to reach at least 20 weeks gestation note that this is the traditional \u002F classic definition of 'nulliparous' and that there is overlap between nulliparity as defined this way and 'preterm birth' due to cervical insufficiency, which allows for deliveries in the 16-19 week gestational age range to be considered as 'preterm births'\n\n     o Obesity: current or pre-pregnancy body mass index ≥30 kg\u002Fm\\^2\n\n     o Family history: first degree relative with a history of preeclampsia\n\n     o Advanced maternal age: maternal age ≥ 35 years at estimated date of confinement\n\n     o Prior adverse obstetric history - one or more of the following:\n\n     \\- history of low birth weight or small for gestational age baby in a singleton gestation, defined as weight \\\u003C10% for gestational age and fetal sex; the fetus must not have had major structural anomalies or aneuploidy.\n\n     \\- history of adverse pregnancy outcome in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.\n\n     o Long interpregnancy interval: ≥ 10 year (3650 day) pregnancy interval, defined as the time (in days) between the date of delivery of the last pregnancy to reach ≥ 20 weeks gestation and the first day of the last menstrual period for the current pregnancy.\n\n     o Black or African-American race (as a proxy for underlying racism) - self-reported. Participants who self-identify as being of more than one racial group will be considered to be of Black race for the purposes of this criterion if one of the racial groups is Black or African-American.\n     * Low socioeconomic status, defined as one or more of the following: housing or food insecurity noted in chart within the last year, self-pay or Medicaid insurance, less than high school education\n\nand\u002For\n\n(3b) High a priori risk for spontaneous preterm birth - must meet at least one of the following 2 criteria (prior pregnancy history or current pregnancy course)\n\n* sPTB criteria #1: Prior pregnancy history\n\n  * EITHER a history of a delivery of a singleton, non-anomalous baby between 16+0 and 34+6 weeks gestation or delivery of a twin, non-anomalous pregnancy between 160 \u002F7and 276 \u002F7 weeks gestation due to spontaneous preterm labor, preterm premature rupture of membranes, cervical insufficiency, or placental abruption - Chart documentation of prior preterm birth, the gestational age of the prior preterm birth (referred to as the 'qualifying delivery') should be determined. If the gestational age at delivery is obtained directly from the medical record and more than one gestational age appears, the greater of the two will be used assuming that neither is the 'source document' (i.e. an ultrasound report with a due date, a c-section report, a delivery note, etc).\n\nUse the following table as a validation of the previous delivery. For example, if the infant was male and weighed more than 2763 grams (6 pounds, 1.5 ounces) then the patient would be ineligible based on history of a preterm birth criteria. This table should only be used to determine whether the qualifying delivery is most likely to be preterm less than 35 weeks gestation when the gestational age CANNOT be verified\u002Fcalculated by review of the medical records or is not available in the medical records.\n\nGestational age 90th percentile - boys 90th percentile - girls 33 weeks \\> 2488g 5 lbs 7.8 oz \\> 2116g 4 lbs 10.6 oz 34 weeks \\> 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\n\n* Documented history of a prior pregnancy complicated by asymptomatic cervical shortening \\\u003C25mm between 16+0 and 23+6 weeks gestation or cervical dilation ≥ 0.5cm requiring cervical cerclage placement prior to 24+0 weeks gestation, even if delivery ultimately occurred ≥ 35 weeks gestation or at term.\n\n  • sPTB criteria #2: Current pregnancy course\n* Asymptomatic cervical shortening \\\u003C25mm in the current pregnancy, diagnosed by transvaginal ultrasound that is performed ≥14+0 weeks gestation, per Registered Diagnostic Medical Sonographer(RDMS) certified Sonographer or physician with transvaginal ultrasound training program (or similar) qualifications\n* Cervical cerclage in situ in the current pregnancy due to concern for risk of preterm birth, at the discretion of the primary obstetric provider\n\n  (4) Ability to provide written, informed consent in English or Spanish\n\n  (5) 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).\n\nExclusion Criteria:\n\n1. 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\u002For confound the study results.\n\n   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.\n2. Previous participation in the PTBCARE+ program in another pregnancy, with randomization to the PTBCARE+ (active intervention) group.\n3. Current, ongoing, illicit drug use ≥ 12 weeks gestation.\n\n   * Use of tobacco and\u002For marijuana products is not an exclusion.\n   * Receiving treatment for opioid use disorder with methadone, suboxone, or similar in an approved treatment program is not an exclusion.\n4. History of radical trachelectomy\n5. Planned voluntary termination of pregnancy.\n6. Heavy vaginal bleeding or large subchorionic hemorrhage - defined as:\n\n   * Bleeding as primary reason for unplanned clinic evaluation or emergency room visit within 14 days of potential enrollment\n   * Subjective bleeding accompanied by ≥ 4 point drop in the hematocrit within 14 days of potential enrollment\n   * Subchorionic hemorrhage or abruption on formal ultrasound with a volume ≥ 64 cubic cm (4cm x 4cm x 4cm) within 14 days of potential enrollment\n7. Major congenital anomaly such as major structural deficit of the heart, lungs, brain, or other major organ system\n\n   1. Mild renal abnormalities, clubfoot, isolated cleft lip\u002Fpalate, etc. in the fetus are not a reason for exclusion.\n   2. Isolated 'soft markers' for aneuploidy (such as choroid plexus cysts, echogenic bowel, etc.) are not a reason for exclusion.\n   3. 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.\n8. 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.\n\n   * 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.\n   * 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.\n9. Cystic hygroma or abnormally thickened nuchal translucency ≥ 3 mm at any time in the current gestation, regardless of subsequent diagnostic testing results.\n\n   * 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.\n   * Fetal echocardiogram is most accurately performed at 22-24 weeks gestation, which is later than the enrollment gestational age window.\n10. Polyhydramnios at or prior to enrollment.\n\n    o Polyhydramnios is defined as a maximum vertical pocket ≥ 8.0 cm, given that polyhydramnios \\\u003C22 weeks has a high likelihood of being associated with congenital anomalies\u002Faneuploidy and\u002For preterm birth due to preterm prelabor rupture of membranes.\n11. 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.\n12. Known HIV positive with viral load greater than 1,000 copies\u002FmL or cluster of differentiation 4 (CD4) count less than 350\u002Fmm\\^3\n13. Unwillingness to undergo randomization.","FEMALE","18 Years",{"count":147,"type":148},1228,"ESTIMATED","INTERVENTIONAL",[151],"NA","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:\n\n* Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy?\n* Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy?\n* Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term?\n\nResearchers 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.\n\nParticipants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care.\n\nAll participants will be asked to:\n\n* 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.\n* 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.\n\nPeople 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:\n\n* a stress reduction toolkit;\n* access to an online website that can also be downloaded as a smart phone app;\n* the option to receive an electronic massage while in clinic, and more.\n* additional support gifts provided at routine clinical appointments\n\nPeople who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.",[154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175],"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",[38,177,178,179],"pregnancy-related disparities","patient support program","enhanced prenatal care","NOT_YET_RECRUITING","2026-06-25",{"date":183,"type":184},"2026-06-29","ACTUAL",{"date":186,"type":148},"2026-08-01",{"date":188,"type":148},"2029-01",{"name":5,"class":6},1]