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North carolina launches massive effort to protect pregnant women from hypertension

NCT ID NCT06744231

Prevention Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a community-based program called Thriving Hearts across ten North Carolina counties. Pregnant individuals at risk for hypertensive disorders receive a care kit with a home blood pressure monitor and stress management tools, plus extra support from healthcare providers and community resources. The goal is to reduce the number of people who develop dangerous high blood pressure during pregnancy. Over 17,000 participants will be involved, and the program will be rolled out in stages to compare outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mama Hearts Care Kit (home blood pressure monitor, stress management tools, and community resource guide) plus behavioral support and provider training
What this could lead to
If successful, this program could lower rates of dangerous high blood pressure during pregnancy and improve outcomes for mothers and babies in participating counties.
What could go wrong
This is a large real-world implementation study, not a controlled drug trial. Results may vary by county, and the program may not reduce complications as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 17,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: Inclusion Criteria: * 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 Exclusion Criteria * \< 15 or \> 55 years of age * 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 Inclusion criteria: * 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 Exclusion criteria: * Age \< 18 * 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

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Conditions

The condition(s) this trial relates to.

hypertensive disorder Toxemia hypertension, pregnancy-induced prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertensive disorder of pregnancy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.