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Doulas and smart devices team up to tackle postpartum hypertension

NCT ID NCT05655936

Disease control Sponsor: University of Pittsburgh 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a specially trained doula, along with home blood pressure and weight monitoring, can improve blood pressure in women who had high blood pressure during pregnancy. About 454 women will be randomly assigned to usual care or the doula program. The goal is to see if this extra support helps women recover better and reduces racial gaps in heart health after childbirth.

What this could mean

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

Active substance
Heart Health Doula Intervention Program (behavioral support, blood pressure cuff, and weight scale)
What this could lead to
If successful, this could provide a practical, community-based way to lower heart risks after pregnancy and reduce racial disparities in maternal health.
What could go wrong
This is a single-site trial with 454 participants, so results may not apply everywhere. The intervention is behavioral, so benefits may vary by individual adherence.

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 454 people

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

Started

Jun 2023

Expected to finish

Jul 2027

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

18 years and older

Sex

Female participants only

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.

Inclusion * Women must be pregnant or postpartum and assessed during pregnancy and/or delivery with a diagnosis of a hypertensive disorder of pregnancy (pre-eclampsia, eclampsia or gestational hypertension). * Women must reside in Allegheny, Westmoreland, Beaver, Butler, or Washington County. Participant may also reside within 100 miles of Allegheny County. * The participant must deliver (or plan to deliver) at Magee-Womens Hospital Exclusion * No pre-pregnancy chronic conditions that affect blood pressure such as hypertension or on antihypertensive medications within 3 months before conception. * No diabetes (type 1 or type 2) * No chronic and severe renal or liver disease or systemic lupus erythematous * No women under the age of 18

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder eclampsia hypertension, pregnancy-induced hypertensive disorder nutritional disorder Obesity obesity disorder Overweight preeclampsia pregnancy disorder Toxemia toxemia of pregnancy vascular disorder

As listed by the trial registrant

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

Cardiovascular diseases Eclampsia Gestational hypertension Hypertension Hypertension, pregnancy induced Hypertensive disorder of pregnancy Nutrition disorders Obesity Overweight Pre-eclampsia Preeclampsia Pregnancy complications Toxemia Vascular diseases

Contacts and locations

Locations

  • Magee Women's Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213, United States

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