An interventional study of Care coordination and Electronic massage in Preterm Birth Complication, Preterm Birth and Preterm Birth Recurrence, sponsored by University of North Carolina, Chapel Hill. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
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:
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:
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:
People who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.
This project addresses the major public health problem of preterm birth (PTB), delivery \<37 weeks, by deploying a novel, personalized, comprehensive 3-tier PTB prevention program [University of North Carolina (UNC) PTBCARE+]. PTB affects 1 in 10 infants born in the United States (US) and is the leading cause of neonatal morbidity and mortality; survivors are at high risk for lifelong adverse health sequelae. Stress is an established risk factor for both spontaneous PTB (sPTB) and medically indicated PTB miPTB). Of significant public health concern, Black patients have 49% higher rates of PTB, are more likely to have early PTB, and increased perceived stress in pregnancy compared to patients of other races. Stress may alter biology, including stress-related gene expression in maternal blood and allostatic load index. Evidence from other fields of medicine supports incorporation of both stress reduction programs and 'patient navigators' as effective approaches to improve health outcomes, and data in obstetrics supports improved outcomes with PTB specialty clinics. However, such programs are not routinely employed in obstetrics. The effect of a specialty prenatal care program targeting stress reduction as a strategy to reduce PTB and PTB disparities remains unknown, representing a critical knowledge gap.
The central hypothesis of this project is that enrollment in a personalized, comprehensive PTB support program (UNC PTBCARE+) is associated with reduced perceived stress, stress-related gene expression, allostatic load, and lower rates of PTB \<35 weeks. This hypothesis is supported by published and preliminary data as follows: First, UNC pregnant patients at high risk for PTB have high rates of stress and life stressors (e.g., financial insecurity, racism). Second, biologic stress markers including gene transcript levels differ by PTB status in mid-pregnancy blood. Third, specialty PTB care reduces stress in a NC cohort. Building upon prior work and that of others, this exciting proposal evaluates the efficacy of the novel UNC PTBCARE+ program.
The investigation focus on PTB \<35 weeks due to its relative frequency, higher association with neonatal morbidity and mortality as compared to later PTB, to include PTB in the 34th week of gestation (because the delivery gestational age considered 'standard of care' for delivery among individuals with stable but severe preeclampsia and preterm membrane rupture), and to align with multiple other published PTB RCTs. This study will recruit 1,350 pregnant patients between 8+0 and 19+6 weeks gestation with an elevated a priori risk of either medically-indicated preterm birth or spontaneous preterm birth. Subjects will be randomized 2:1 to receive UNC PTBCARE+ vs. usual care. Randomization will be stratified based on maternal race and ethnicity (individuals who identify only as White and non-Hispanic vs. individuals who identify as belonging to one or more other races and/or Hispanic ethnicity and (b) perceived stress scores (those with perceived stress scores ≥20 vs. those with lower perceived stress scores scores).
All participants, regardless of randomization assignment, will have 2 study visits during pregnancy.
At both visits, patients will complete validated surveys evaluating a broad spectrum of stressors, discrimination, adverse childhood experiences, perceived social support, resiliency, medication barriers and adherence, care access and satisfaction,, intervention fidelity and sustainability, use of stress relief modalities, and have blood collected to measure biologic stress markers.
The UNC PTBCARE+ program is personalized. All patients randomized to UNC PTBCARE+ receive a stress reduction toolkit and will work with a PTB Care Coordinator who will provide support, facilitate clinician-prescribed medical care, and serve as a patient-provider liaison. Additional benefits / support items and support elements are provided to some participants on an "as needed" basis, per study protocol, and are not included in the initial registration to preserve scientific integrity and protect the rights of research participants. This study registration will be updated with complete intervention details after the study is fully enrolled and all participants have delivered.
Psychosocial and financial stressor screening results from V1 will determine UNC PTBCARE+ tier assignment. Thus, participants are randomized only after Visit 1 surveys are completed.
This solutions-oriented RCT of UNC PTBCARE+ vs. usual care provides an ideal forum to test the primary hypothesis and study stress-related PTB pathophysiology through the following Aims:
This study provides tangible, personalized solutions to the major public health problem of PTB and carries enormous potential to provide generalizable, low-risk strategies to reduce PTB and related disparities.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 1,228 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
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.
Maternal chronic or sub-acute renal disease, including chronic kidney failure, chronic renal insufficiency, glomerulonephritis, lupus nephritis, defined as any:
* 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
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).
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 / 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'
o Obesity: current or pre-pregnancy ≥30 kg/m\^2
o Family history: first degree relative with a history of preeclampsia
o Advanced maternal age: maternal age ≥ 35 years at estimated date of confinement
o Prior adverse obstetric history - one or more of the following:
- history of low birth weight or small for gestational age baby in a singleton gestation, defined as weight \<10% for gestational age and fetal sex; the fetus must not have had major structural anomalies or aneuploidy.
- history of adverse pregnancy outcome in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.
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.
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.
and/or
(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)
sPTB criteria #1: Prior pregnancy history
Use 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/calculated by review of the medical records or is not available in the medical records.
Gestational 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
Documented history of a prior pregnancy complicated by asymptomatic cervical shortening \<25mm 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.
Cervical cerclage in situ in the current pregnancy due to concern for risk of preterm birth, at the discretion of the primary obstetric provider
(4) Ability to provide written, in English or Spanish
(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).
Exclusion Criteria:
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.
Current, ongoing, illicit drug use ≥ 12 weeks gestation.
Heavy vaginal bleeding or large subchorionic hemorrhage - defined as:
Major congenital anomaly such as major structural deficit of the heart, lungs, brain, or other major organ system
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.
Cystic hygroma or abnormally thickened nuchal translucency ≥ 3 mm at any time in the current gestation, regardless of subsequent diagnostic testing results.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
Research team members will serve as research assistants and will also function as perinatal care coordinators. In 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 / care coordinator by text, email, phone, or through the electronic medical record participant portal. \- 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). Research staff may also meet in person with participants prior to visit 1 for recruitment/enrollment purposes.
Also known as: PTBCARE+
Participant is given the option to receive a 15-minute electronic massage / 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. * the electronic massages provide gentle massages and are safe for most people to use throughout pregnancy. * participants are always be in control of the massage experience and will be given instructions on how to stop the massage at any time. * participants are advised to consult the primary obstetric provider before using the massage chair regarding any specific concerns or questions * during the session, participants may view relaxation videos (from free, publicly available sites online). * participants may choose to sign up for massage(s) at any obstetric visit in the clinic between visit 1 and delivery.
Also known as: Massage chair, Relaxation session
* 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). * Given between 14+0 and 23+6 weeks gestation at time of routine prenatal appointment
Also known as: cool calm and collected support gift
* 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). * Given between 18+0 and 27+6 weeks gestation at time of routine prenatal appointment
Also known as: Keep moving forward support gift
* 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). * Given between 22+0 and 29+6 weeks gestation at time of routine prenatal appointment
Also known as: Small acts, big impact: pass it on
* 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). * Given between 26+0 and 33+6 weeks gestation at time of routine prenatal appointment
Additional benefits / support items and support elements are provided to some participants on an "as needed" basis, per study protocol. * Information / 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 * 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
In person check-in with research team member re: participant's needs; research team member provides support. Physical items that are included as part of this visit include: Tote bag with the following stress reduction items or similar: * eye mask * set of pocket index cards, printed back and front, on a variety of topics that influence pregnancy health, ranging from physical to emotional/mental * water bottles * small notebook * pill minder case * magnet and business card for Health Resources and Services Administration (HRSA) national maternal mental health hotline * log in codes for electronic resources * initial handouts with self care plan, introduction to stress reduction toolkit, etc.
Also known as: V1 Stress toolkit
Comprehensive, study-specific app that is available as a website or as a downloadable application that includes personalized, interactive modules and resources * no study related materials are available without a password * goal is to collate reputable sources of information to make investigating things online easier * includes optional educational modules for participants * 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 * available online (computer/laptop), tablet, or smart phone. can be downloaded as a progressive web application (PWA) to a local device and used without internet access * Electronic access to the PTBCARE+ website will continue through 10 weeks postpartum unless the participant delivered \<16+0 weeks gestation in which case access will continue through 4 weeks postpartum
Also known as: PTBCARE+ website, PTBCARE+ 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! * Participants can access this app as needed throughout pregnancy and beyond, for up to one year after the date of enrollment
Pouch contains: * printed index card with information about signs and symptoms of low blood sugar * printed index card with information about what to do if blood sugar is low * 2-3 non-perishable, individually wrapped over the counter candy / glucose-raising options; use for low blood sugar treatment is described on the card Only 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. Each participant can receive a maximum of two kits during pregnancy; first at enrollment, and the other at visit 2 or until delivery
* Bottle of 90-100 pills (depending on manufacturer) * Provided at Visit 1 (after randomization) * Patients who received a bottle of low-dose aspirin at Visit 1 are offered a 2nd bottle at Visit 2. All 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+ Please 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.
In person check-in with research team member re: participant's needs; research team member provides support. Physical items that are included as part of this visit include the following stress reduction items or similar: 1. Frame + ultrasound photo + certificate of achievement! * Picture from anatomy ultrasound (or other subsequent ultrasound) is downloaded, printed, and placed in frame. * Certificate of achievement is printed and placed on other side of frame with ultrasound photo 2. other small items including stickers, printed index cards with supportive messaging, etc.
Also known as: Celebrate Today, Believe in Tomorrow
Self-reported Perceived Stress Scores
Perceived Stress Scale participant survey * Scores range 0-40 * Higher scores = higher stress
Time frame: 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
Brief Resilience Scale validated participant survey * score range = 1-5 * higher scores = higher resilience
Time frame: 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
Each participant's fold change in blood-based stress-related gene transcript levels during pregnancy, calculated as a ratio: (visit 2 gene expression - visit 1 gene expression) divided by visit 1 gene expression.
Time frame: 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
Number of participants who either delivered or experienced a fetal death at a gestational age between 14 weeks 0 days and 35 weeks 0 days gestation. Pregnancies that are lost in the first trimester (prior to 14 weeks of gestation) are excluded from analysis.
Time frame: 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.
Self-reported (subjective) allostatic load
Allostatic load = balance between stress and stress-protective factors. This is a single outcome determined by a comprehensive, study-specific calculation from weighted normalized (0-1 scale) data from participant surveys. Subjective allostatic load = \[(Normalized Stress - Normalized Stress-protective factors)/2\] * score range -1 to +1 * higher scores = higher allostatic load (more stress than protective factors)
Time frame: 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 composite "negative" stress
Subjectively reported composite "negative" stress, which is a single outcome measure calculated by considering participant responses on three surveys. Each survey score total is normalized on a 0-1 scale based on each individual's score in relation to the max possible score for that survey. The 3 normalized scores are then averaged to obtain the single composite negative stress score (range is 0-1), whereby a higher scores = higher negative stress.
Time frame: 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 composite severe maternal morbidity
Diagnosis of severe maternal morbidity during pregnancy or the initial postpartum period, defined using indicators by the Centers of Disease Control and Prevention (CDC). Individuals who are diagnosed with one or more of the following by a clinician and with appropriate radiologic / laboratory findings to support the diagnosis are considered to have this outcome: acute myocardial infarction, aneurysm, acute renal failure, adult respiratory distress syndrome, amniotic fluid embolism, cardiac arrest / ventricular fibrillation, conversion of cardiac rhythm, disseminated intravascular coagulation, eclampsia, heart failure / arrest during surgery or procedure, puerperal cerebrovascular disorders, pulmonary edema / acute heart failure, severe anesthesia complications, sepsis, shock, sickle cell disease with crisis, air and thrombotic embolism, hysterectomy, temporary tracheostomy, or ventilation. Need for blood transfusion is considered separately, as per prior work.
Time frame: Enrollment through the postpartum followup period of 10 weeks after delivery, a period of up to 45 weeks from enrollment (assuming latest possible delivery gestational age is 43 weeks)
Perceived Social Support scores
Social support is quantified by the Medical Outcomes Study (MOS) social support survey * score range: 0 to 100 * High score: Indicates a strong perception of social support, with readily available people to provide assistance and emotional support. * Low score: Suggests a perceived lack of social support, potentially indicating a need for additional social connections or support systems.
Time frame: 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
Satisfaction with medical care
Determined by the self-administered Patient Satisfaction Questionnaire - 18 question (PSQ-18) survey, which measures satisfaction with medical care across 7 different domains: (1) General satisfaction (2) Technical quality; (3) Interpersonal manner; (4) Communication; (5) Financial aspects; (6) Time spent with doctor; (7) Accessibility and convenience * score range = 18 to 90 * score interpretation: a higher score indicates greater patient satisfaction with their healthcare provider
Time frame: 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 anxiety symptoms
Each participant's subjectively reported anxiety, assessed by the self-administered Generalized Anxiety Disorder - 7 (GAD-7) survey Score range: 0 to 21 Score interpretation: higher scores = higher anxiety
Time frame: Mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 22 weeks from enrollment
Self-reported perinatal depression symptoms
Depression symptoms are assessed by the Edinburgh Postnatal Depression Scale (EPDS). Scoring: range 0-30 Interpretation: higher scores are associated with higher possibility of depression
Time frame: Initial pregnancy intake (administered during routine clinical care during pregnancy, as early as 4 weeks pregnant to 19+6 weeks) and mid-pregnancy followup (Visit 2 - 22+0 to 29+6 week), a period of up to 26 weeks from enrollment
Self-reported pregnancy experiences
The self-administered pregnancy experiences scale and includes: * 10 questions on 'Hassles' with a total hassles score ranging from 0 to 30. Higher Scores: Higher scores on the hassles dimension indicate greater perceived stress and negative experiences during pregnancy. * 10 questions on 'uplifts' with a total uplifts score ranging from 0 to 30. Higher scores on the uplifts dimension indicate more positive experiences and emotional upliftment. The Composite Measure Score=Total Uplifts Score-Total Hassles Score; Score range = -30 to +30. Interpretation: A positive composite score indicates that the positive experiences (uplifts) outweigh the negative experiences (hassles), suggesting a more positive overall pregnancy experience. Conversely, a negative composite score indicates that hassles outweigh uplifts.
Time frame: 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-assessed generalized self-efficacy
The Generalized Self-Efficacy Scale (GSE) is a 10-item, widely used tool to assess an individual's belief in their ability to handle various challenging situations. Each item is rated on a 4-point scale: Total Score: The scores for each item are summed to provide a total score, which ranges from 10 to 40. Interpretation: Higher Scores: Indicate a stronger belief in one's ability to cope with difficult situations and achieve goals. Lower Scores: Suggest lower confidence in one's ability to manage challenges and may indicate a need for interventions to boost self-efficacy.
Time frame: 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-assessed overall health
Each participant's change in their perception of their overall physical health, as assessed by the 10 question Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Survey Rating: Each item is rated on a 5-point Likert scale. Responses are summed to create raw scores for physical and mental health. Raw scores are converted to T-scores using standardized tables. T-scores have a mean of 50 and a standard deviation (SD) of 10, based on the general population. Interpretation: T-Scores at 50 are Representative of the average score of the general population. Above 50: Indicates better than average health. Below 50: Indicates worse than average health.
Time frame: 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 coping strategies
Coping strategies are assessed by the participant reported survey, Coping Strategies Inventory - Short Form (CSI-SF). The CSI-SF has 16 items, 4 per each of 4 sub-scales: 1. Problem-Focused Engagement 2. Problem-Focused Disengagement 3. Emotion-Focused Engagement 4. Emotion-Focused Disengagement Total for each subscale = 4-20. * Range for positive coping (adding 2 "engagement" sub-scales) is 8-40 * Range for negative coping (adding 2 "disengagement" sub-scales) is 8-40. The positive coping score is then divided by the negative coping score to provide a ratio of positive to negative coping, ranging from 0.2 to 5. Interpretation: Higher scores on each sub-scale indicate more frequent use of that coping strategy. Thus, a higher positive:negative coping strategy ratio suggests a more adaptive/positive coping style whereas lower ratios suggest less adaptive/more negative coping.
Time frame: 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-assessed overall well-being
Overall wellbeing is self-assessed by the Positive Emotion, Engagement, Relationships, Meaning, and Accomplishment (PERMA) Profiler, which measures these 5 key well-being domains. The 5 PERMA domains are averaged to provide an assessment of overall health. The instrument also includes measures for Negative Emotion and Health. Scoring Range: each PERMA domain is assessed using three items, rated on a scale from 0 (Never) to 10 (Always). Scores for each domain are averaged to provide a domain score. The overall PERMA score is an average of all scores and ranges from 0-10. Negative Emotion and Health are also assessed using three items each, rated on the same 0 to 10 scale, and averaged. Scoring Interpretation: Higher scores indicate higher levels of well-being in the respective domain.
Time frame: 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
Subjective report of physical activity
Physical activity is quantified by the Pregnancy Physical Activity Questionnaire Short Form (PPAQ-SF). Scoring: The 10 question PPAQ-SF measures physical activity across several domains: (1) Household/Caregiving; (2) Occupational; (3) Sports/Exercise; (4) Transportation; (5) Locomotion. Each activity is categorized by intensity: Light activities = 1.5-2.9 metabolic equivalents (METs); moderate activities = 3.0-5.9 METs; vigorous activities = ≥ 6.0 METs. Score calculation / range / interpretation: MET hours/week = MET value of activity x hours spent on that activity/week. Higher scores = more active. Theoretically, the minimum score is 0 MET hours/week, indicating no physical activity; there is no strict upper limit, but extremely high scores (\>10,000) = uncommon, may indicate over-reporting.
Time frame: 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
Delivery gestational age
Participant's delivery gestational age or gestational age at time they are diagnosed with an in-utero fetal death. Delivery gestational age is considered continuously, in weeks and days of gestation. Pregnancies that are lost in the first trimester (prior to 14 weeks of gestation) are excluded from analysis. Therefore the possible range of gestational age entries is 14 weeks 0 days (earliest) through 43 weeks 0 days (generally the latest possible gestational age).
Time frame: From the time of enrollment (if > 14 weeks 0 days) or 14 weeks 0 days to delivery (may occur as late as 43+0 weeks), a period of up to 35 weeks from enrollment
Objective allostatic load index
Each participant's objective allostatic load index will be calculated using clinical parameters including blood pressure, pulse pressure, and body mass index, etc. based on the published literature. Score range = normalized, 0 to 100 scale. Score interpretation = higher allostatic load score = higher allostatic load
Time frame: 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 less than 37 weeks gestation
Number of participants who either delivered or experienced a fetal death at a gestational age between 14 weeks 0 days and 37 weeks 0 days gestation. Pregnancies that are lost in the first trimester (prior to 14 weeks of gestation) are excluded from analysis.
Time frame: Between 14 weeks 0 days and 37 weeks 0 days gestation (delivery at 36 weeks 6 days gestation meets this outcome; delivery at 37 weeks 0 days gestation does not) , a period of up to 29 weeks from enrollment.
Number of participants with preterm birth or fetal death less than 32 weeks gestation
Number of participants who either delivered or experienced a fetal death at a gestational age between 14 weeks 0 days and 32 weeks 0 days gestation. Pregnancies that are lost in the first trimester (prior to 14 weeks of gestation) are excluded from analysis.
Time frame: Between 14 weeks 0 days and 37 weeks 0 days gestation (delivery at 31 weeks 6 days gestation meets this outcome; delivery at 32 weeks 0 days gestation does not) , a period of up to 24 weeks from enrollment.
Number of participants with preterm birth or fetal death less than 28 weeks gestation
Number of participants who either delivered or experienced a fetal death at a gestational age between 14 weeks 0 days and 28 weeks 0 days gestation. Pregnancies that are lost in the first trimester (prior to 14 weeks of gestation) are excluded from analysis.
Time frame: Between 14 weeks 0 days and 28 weeks 0 days gestation (delivery at 27 weeks 6 days gestation meets this outcome; delivery at 28 weeks 0 days gestation does not) , a period of up to 20 weeks from enrollment.
Number of participants with preterm birth or fetal death less than 24 weeks gestation
Number of participants who either delivered or experienced a fetal death at a gestational age between 14 weeks 0 days and 24 weeks 0 days gestation. Pregnancies that are lost in the first trimester (prior to 14 weeks of gestation) are excluded from analysis.
Time frame: Between 14 weeks 0 days and 24 weeks 0 days gestation (delivery at 23 weeks 6 days gestation meets this outcome; delivery at 24 weeks 0 days gestation does not) , a period of up to 16 weeks from enrollment.
Number of participants with composite placental complications
Development of placental complications during pregnancy, defined as one or more of the following: 1. placental abruption (diagnosed clinically) ± birthweight \<3% for fetal sex and delivery gestational age ± 2. diagnosis of hypertensive disorders of pregnancy (including gestational hypertension, chronic hypertension with superimposed preeclampsia, preeclampsia, eclampsia) ± 3. intrauterine fetal demise
Time frame: Baseline (Visit 1 - 8+0 to 19+6 weeks) until delivery (may occur as late as 43+0 weeks), a period of up to 35 weeks from enrollment
Parasympathetic Nervous System Index
Parasympathetic Nervous System (PNS) function is assessed using participant heart rate variability data collected using a continuous heart rate sensor (finger or ear clip) using publicly available Kubios heart rate variability software. PNS Index range: -5 to +5. Interpretation: A PNS index value of zero indicates that the parameters reflecting parasympathetic activity are, on average, equivalent to those of the normal population. Positive index values signify higher parasympathetic nervous system activity and lower stress; lower values indicate lower parasympathetic activity and increased stress.
Time frame: 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
Sympathetic Nervous System Index
Sympathetic Nervous System function is assessed via the Sympathetic Nervous System (SNS) Index using participant heart rate variability data collected using a continuous heart rate sensor (finger or ear clip) using publicly available Kubios heart rate variability software. SNS Index range: typically -5 to +5, may fall outside of range. Interpretation: A SNS index of zero indicates average sympathetic activity compared to the norm. Positive values reflect sympathetic activity levels above the norm, while negative values indicate lower than average activity. During stress or intense exercise, the SNS index can range significantly higher, potentially reaching values between 5 and 35.
Time frame: 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 composite neonatal morbidity
Neonates born to participants are considered to have composite major neonatal morbidity, if, prior to initial hospital discharge from the delivery hospitalization, they are diagnosed by a clinician with one or more of the following diagnoses: 1. bronchopulmonary dysplasia 2. intraventricular hemorrhage grade III or IV 3. periventricular leukomalacia 4. necrotizing enterocolitis requiring surgery 5. death
Time frame: Neonatal outcomes are evaluated until initial hospital discharge or 45 weeks post menstrual age, a period of up to 37 weeks from maternal enrollment and up to 23 weeks of age for the neonate (if born at 22 weeks 0 days).
Heart Rate Variability
Heart Rate Variability (HRV) is assessed using data collected from participants by a continuous heart rate sensor (finger or ear clip) and calculated using publicly available HeartMath / EmWave Pro heart rate variability software. HRV values are reported as a continuous integer and range from 1 - 120 (typical expected upper limit, but may be higher in isolated situations). Interpretation: Higher HRV: Generally associated with better cardiovascular health and greater resilience to stress. Lower HRV: Can indicate higher stress levels, poor cardiovascular health, or other health issues
Time frame: 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 who are diagnosed with hypertensive disorders of pregnancy
Development of hypertensive disorders of pregnancy, one of the elements of the composite placental complications (outcome #24), defined as a diagnosis of gestational hypertension, chronic hypertension with superimposed preeclampsia, preeclampsia, and/or eclampsia through the postpartum followup period.
Time frame: Baseline (Visit 1 - 8+0 to 19+6 weeks) until delivery (may occur as late as 43+0 weeks), a period of up to 35 weeks from enrollment
Level of engagement with PTBCARE+ intervention
Considering only those randomized to the PTBCARE+ intervention, the investigators will evaluate the percentage of eligible activities completed considered as a continuous variable (range = 0-100, with higher numbers indicating higher participation and engagement).
Time frame: Baseline (Visit 1 - 8+0 to 19+6 weeks) until delivery (may occur as late as 43+0 weeks), a period of up to 35 weeks from enrollment
Autonomic function evaluation
Autonomic function will be calculated by dividing Sympathetic Nervous System (SNS) function index (outcome #26) by Parasympathetic Nervous System (PNS) function index (outcome #27). Values are obtained using participant heart rate variability data collected using a continuous heart rate sensor (finger or ear clip) using publicly available Kubios heart rate variability software. This ratio is a continuous variable that will vary based on SNS index value (expected -5 to +5) and PNS index values (expected -5 to +5), and thus will range -25 to +25. Higher values = higher sympathetic nervous system activity (stressed) relative to parasympathetic activity (relaxed).
Time frame: 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
Interval between study enrollment and delivery or in-utero fetal death.
The interval between study enrollment and delivery or diagnosis of in utero fetal demise (the period of "latency") will be considered as a continuous variable (in days/weeks), determined by the following formula: Participant delivery gestational age or gestational age at time they are diagnosed with an in-utero fetal death minus the gestational age at study enrollment. The possible range of values is 0 days (if delivery occurs same day as study enrollment, albeit unlikely) to 35 weeks (245 days) if the participant enrolls at the earliest possible gestational age of 8 weeks 0 days and delivers at 43 weeks 0 days (generally the latest possible gestational age).
Time frame: From the time of enrollment to delivery (may occur as late as 43+0 weeks), a period of up to 35 weeks from enrollment
Amount of gestational weight gain
Amount of weight gained, in pounds, during pregnancy. Calculated by considering: Last recorded weight during pregnancy minus the pre-pregnancy weight if measured at medical facility / clinic within 3 months' of last menstrual period (LMP) or calculated start of pregnancy using the best estimated date of conception (EDC), or, if this is unavailable, the earliest recorded weight at a medical facility / clinic during pregnancy. Considered as a continuous variable, typical expected range -20 pounds to +100 pounds, though outliers may occur. Higher numbers indicate higher weight gain during pregnancy. Negative numbers reflect weight loss during pregnancy.
Time frame: Captured at enrollment and at delivery (may occur as late as 43+0 weeks), a period of up to 35 weeks from enrollment
Level of satisfaction with PTBCARE+ intervention
Considering only those randomized to the PTBCARE+ intervention, the investigators will evaluate overall participant satisfaction with the intervention using a study-specific survey. Satisfaction scores will be summed and normalized on a scale of 0-100, with higher scores indicating higher satisfaction with the packaged intervention.
Time frame: Enrollment through the postpartum followup period of 10 weeks after delivery, a period of up to 45 weeks from enrollment (assuming latest possible delivery gestational age is 43 weeks)
Number of participants requiring a blood transfusion during pregnancy or the immediate postpartum time period
Need for blood transfusion is one of 21 indicators used to identify severe maternal morbidity, as per the Centers of Disease Control and Prevention. However, receiving a blood transfusion can sometimes not accurately reflect a true severe complication on its own. Small blood transfusions may be administered routinely even without a major adverse event, potentially inflating the rate of severe maternal morbidity if included without further context. Thus, need for blood transfusion during pregnancy or the immediate postpartum time period (through the time of discharge from delivery hospitalization), is evaluated separately.
Time frame: Enrollment through the postpartum followup period of 10 weeks after delivery, a period of up to 45 weeks from enrollment (assuming latest possible delivery gestational age is 43 weeks)
Plan to share: Yes — De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication of initial results provided the investigator who proposes to use the data: submits a proposal to the study investigative team regarding the planned use of the data, and: the data analysis plans fall under the scope of written, informed consent as per the participant consent form; the proposed analysis does not directly conflict with a pre-specified analysis planned by the primary investigative team at UNC; (as applicable, based on the request) the proposed individual patient data (IPD) request involves a sufficient number of individuals within individual subgroups such that individual participants cannot be readily identified by review of the IPD. has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable; and executes a data use/sharing agreement with UNC.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication of initial results provided the investigator who proposes to use the data in accordance with the guidelines outlined above in the plan description. The study protocol, statistical analysis plan, and informed consent forms will be shared beginning 3 months following delivery of the final study participant, given the importance that several study details are redacted during the study to preserve study integrity and protect research subjects.
Access criteria: Who will have access? Researchers \& Investigators: Qualified researchers/investigators with legitimate scientific requests. Public: Data may be made available to the public, depending on the ethical considerations and the purpose of data request. Access requests will be reviewed by the investigative team to ensure protection of participant privacy is maintained as per the consent form(s) and IRB. What will they be able to access? A subset of the "minimum necessary" de-identified data to fulfill the objectives outlined in the requestor's proposal Access to study protocols, statistical analysis plans, and informed consent documents. How will they access it? - Researchers must submit a formal data access request, similar to request forms that are required to access data through dbGAP and other similar online data repositories. Approved individuals will be able to download de-identified data and supporting documentation from a secure online portal.
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