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Warm legs, healthy pregnancy? new study tests heat therapy for Moms-to-Be

NCT ID NCT06932250

Prevention Sponsor: University of Texas Southwestern Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether regularly warming the legs with a portable sauna blanket can improve blood vessel health and lower the risk of high blood pressure disorders in pregnant women with obesity. About 118 women will use the blanket at home for 16 weeks, starting early in pregnancy. Researchers will measure changes in blood vessel function and nerve activity to see if this simple, drug-free approach works.

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 118 people

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

Started

Aug 2025

Expected to finish

Apr 2030

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 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 Criteria: * Women with overweight or obesity (self-reported pre-pregnancy body mass index ≥25 kg/m2) between 10-14 weeks of gestation and aged 18-45 years old will be enrolled. * Both normotensive and hypertensive (office sitting systolic BP 140-150 mmHg and/or diastolic BP 90-100 mmHg) pregnant women will be enrolled if they are not on any antihypertensive drug treatment. * We will enroll both nulliparous and multiparous women. * There is no restriction regarding race/ethnicity and socioeconomic status. * Women with a history of HDP will be allowed to participate. * Women taking low-dose aspirin will be allowed to participate and aspirin use will be documented. Exclusion Criteria: * Current multiple pregnancies (e.g., twins, triplets, etc.). * Known major fetal chromosomal or anatomical abnormalities diagnosed during the study. * Recurrent miscarriage (three or more, to avoid antiphospholipid antibody syndrome). * Office sitting BP \<100/55 mmHg or \>150/100 mmHg (for safety reasons). * Evidence of cardiovascular, pulmonary, or neurological diseases. * Diabetes mellitus (to avoid its effects on vascular endothelial function and sympathetic vasoconstriction). * Kidney disease (serum creatinine \>0.9 mg/dL). * Clinical known deep vein thrombosis, clinical symptoms and history of deep vein thrombosis, or dermatological lesions. * History of drug or alcohol abuse within the last 2 years. * Current tobacco use. * Pregnant women who do not have air conditioning at home during summer (for safety reasons).

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Conditions

The condition(s) this trial relates to.

hypertension, pregnancy-induced Hyperthermia Obesity obesity disorder

As listed by the trial registrant

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

High-risk 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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine

    RECRUITING

    Dallas, Texas, 75231, United States

More trials for these conditions

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