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

ConditionsPreterm 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

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorUniversity of North Carolina, Chapel Hill

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

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

Disqualifiers

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.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Care coordination
Behavioral
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.
Electronic massage
Behavioral
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.
support gift #1
Behavioral
* 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
Support gift #2
Behavioral
* 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
Support gift #3
Behavioral
* 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
Support gift #4
Behavioral
* 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 PTBCARE+ support
Behavioral
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
Stress reduction toolkit - Visit 1 (V1)
Behavioral
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.
PTBCARE+ mobile application (app) and website
Behavioral
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
Sleep, meditation, and Wellness app
Behavioral
* 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
Emergency low blood sugar kit
Behavioral
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
Low dose aspirin (LDA)
Behavioral
* 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.
Visit #2 Stress Reduction Toolkit
Behavioral
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.

Treatment groups

1,228 Participants

are divided into 2 treatment groups

Group A: Personalized Toolkit Building a Comprehensive Approach to Resource (PTBCARE+) Support ProgramActive comparator 13 interventions

Group B: Usual Prenatal CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Source ClinicalTrials.gov

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