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

NANot yet recruitingINTERVENTIONAL
Enrollment

1,228

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

August 31, 2028

Study Completion Date

January 31, 2029

Conditions
Preterm Birth ComplicationPreterm BirthPreterm Birth RecurrencePreeclampsiaPreeclampsia (PE)Hypertensive Disorders of PregnancySupport ProgramStressResilience, PsychologicalEmpowerment, PatientEmotional StressPregnancyPregnancy ComplicationsPregnancy Induced HypertensionNeonates and Preterm InfantsCervical InsufficiencySocial Determinants of Health (SDOH)Cervical ShorteningDisparities in Pregnancy ComplicationsDisparitiesPrenatal CareCare Coordination
Interventions
BEHAVIORAL

Care coordination

"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."

BEHAVIORAL

Electronic massage

"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."

BEHAVIORAL

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).~* Given between 14+0 and 23+6 weeks gestation at time of routine prenatal appointment"

BEHAVIORAL

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).~* Given between 18+0 and 27+6 weeks gestation at time of routine prenatal appointment"

BEHAVIORAL

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).~* Given between 22+0 and 29+6 weeks gestation at time of routine prenatal appointment"

BEHAVIORAL

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).~* Given between 26+0 and 33+6 weeks gestation at time of routine prenatal appointment"

BEHAVIORAL

Additional PTBCARE+ support

"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"

BEHAVIORAL

Stress reduction toolkit - Visit 1 (V1)

"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."

BEHAVIORAL

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~* 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"

BEHAVIORAL

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!~* Participants can access this app as needed throughout pregnancy and beyond, for up to one year after the date of enrollment"

BEHAVIORAL

Emergency low blood sugar kit

"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"

BEHAVIORAL

Low dose aspirin (LDA)

"* 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."

BEHAVIORAL

Visit #2 Stress Reduction Toolkit

"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."

Trial Locations (1)

27599

University of North Carolina School of Medicine - Chapel Hill, Chapel Hill

All Listed Sponsors
collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

lead

University of North Carolina, Chapel Hill

OTHER

NCT06915428 - Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities | Biotech Hunter | Biotech Hunter