NCT06744231Enrolling by invitation
Thriving Hearts: Healing-Centered, Integrated, Community Maternity Care
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
The overarching goal of Thriving Hearts is to implement a multi-level program through Local Health Departments (LHDs) that cultivates conditions for mothers and birthing people to not only survive pregnancy, but to thrive. Thriving Hearts is a collaboration among LHDs in ten North Carolina counties, designed to reduce incidence of Hypertensive Disorders of Pregnancy (HDP) and their complications through support and connection at the individual, healthcare provider, and community level. The investigators will conduct a pragmatic, stepped-wedge, cluster randomized study. Participating LHDs will begin in a usual care phase, and they will transition to Thriving Hearts in clusters in a randomly assigned sequence at 9-month intervals.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 17500 (estimated)
- First submitted
- 12 Dec 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- High blood pressure
- NCT number
- NCT06744231
What you commit to
- Study type: Interventional
- Planned participants: 17500
- From 1 Jan 2025 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- \< 15 or \> 55 years of age
- Age \< 18
Other
- Did not have a live birth at \>= 24 weeks in the past 6 months
- Residential address not listed on birth certificate as one of the study counties
- Not able to communicate in either English
- Cross-sectional survey of people who serve perinatal patients
- To assess the effectiveness of the Healing Centered Engagement program, the team will conduct cross-sectional surveys of people who serve perinatal patients in Thriving Hearts counties, repeated during each of the six study time periods
- Does not provide services for perinatal patients in a Thriving Hearts county (Alamance, Caswell, Chatham, Cumberland, Durham, Forsyth, Guilford, Johnston, Orange, and Person counties)
- Are unable to communicate in English
Who the study is looking for
- Age ≥15 and ≤55
- Had a live birth at \>=24 weeks in the past 6 months
- Listed the birthing parent's residential address on the birth certificate as within a Thriving Hearts county ( Alamance, Caswell, Chatham, Cumberland, Durham, Forsyth, Guilford, Johnston, Orange, and Person counties)
- Are able to communicate in English or Spanish
- Age ≥ 18
- Provides services for perinatal patients in a Thriving Hearts county (Alamance, Caswell, Chatham, Cumberland, Durham, Forsyth, Guilford, Johnston, Orange, and Person counties)
- Are able to communicate in English
Criteria the registry did not label
- Any individual who is pregnant or \<4 months postpartum and resides in county where Thriving Hearts is active can engage with Thriving Hearts-supported programs and services.
- Cross-sectional survey of postpartum people
- For participation in the population-based survey of postpartum parents, the following criteria are required:
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.