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Leg Heating for Pregnant Women with Obesity

This study is looking at whether home-based leg heating can help pregnant women with obesity. Obesity can increase the risk of high blood pressure during pregnancy (hypertensive disorders of pregnancy, or HDP). Researchers believe that problems with blood vessel function (vascular endothelial dysfunction) and increased nerve activity (sympathetic vasoconstriction) might play a role. Participants will use a portable sauna blanket on their legs at different temperatures. The study will measure changes in blood vessel function and nerve control after 16 weeks of leg heating to see if this intervention is helpful. They plan to enroll 118 women between 18 and 45 years old who are 10-14 weeks pregnant and have overweight or obesity.

Study design
This interventional study plans to enroll 118 women. The phase of the study is not specified.
What's involved
Participants will perform home-based leg heating using a portable sauna blanket. Measurements of blood vessel function and nerve control will be taken at the beginning of the study and again 16 weeks after leg heating.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 16 weeks after starting leg heating to measure changes in blood vessel function and nerve control.

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NCT06932250

Leg Heating in Pregnant Women With Obesity

Recruiting
NAAges 18–45Interventional
University of Texas Southwestern Medical Center
~118 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:Leg heating

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in vascular endothelial function
Measured over Baseline, 16 weeks after leg heating
+2 more outcomes measured

Conditions

High-risk Pregnancy

Explore related trials

ObesityPregnancy

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Qi Fu, MD, PhD · PRINCIPAL_INVESTIGATOR · UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine

Who to contact

Qi Fu, MD, PhD
[email protected]
214-345-8125
Email the study team

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Change in vascular endothelial functionBaseline, 16 weeks after leg heating

    Change in vascular endothelial function assessed by brachial artery flow-mediated vasodilation using the Doppler ultrasound technique

  • Change in sympathetic neural controlBaseline, 16 weeks after leg heating

    Change in sympathetic neural control assessed by muscle sympathetic nerve (re)activity using the microneurographic technique

  • Change in sympathetic vascular transductionBaseline, 16 weeks after leg heating

    Change in sympathetic vascular transduction assessed using the microneurographic and Doppler ultrasound techniques