Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT06932250

Leg Heating in Pregnant Women With Obesity

Led by University of Texas Southwestern Medical Center · Updated on 2026-04-17

118

Participants Needed

1

Research Sites

247 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Obesity is a major risk factor for hypertensive disorders of pregnancy (HDP). The underlying mechanisms are largely unclear, but maternal vascular endothelial dysfunction is likely involved. Endothelial dysfunction in HDP could be attributed to 1) alterations in the L-arginine/nitric oxide (NO) pathway, and 2) an increase in endothelin-1 (ET-1). Additionally, augmented sympathetic vasoconstriction may also contribute to HDP. Chronic (repeated) whole-body heat exposure has been shown to increase NO bioavailability, decrease ET-1, and cause functional and structural adaptations in the vasculature. All these can improve vascular function, attenuate sympathetic (re)activity, lower blood pressure (BP), and reduce cardiovascular risk in non-pregnant individuals. Whether this is also true after regional (leg) heating in high-risk pregnant women is unknown. The investigators' central hypothesis is that chronic leg heating will be effective in improving vascular endothelial function and attenuating sympathetic vasoconstriction, leading to a reduction of the risk for HDP in pregnant women with obesity. The overarching goal of this proposal is to determine the vascular and neural effects of chronic leg heating in obese pregnancy. The study team plans to enroll pregnant women with obesity between 12-14 weeks of gestation and randomly assign them to either an intervention group or a control group (1:1 ratio). Participants in the intervention group will perform 16 weeks of home-based leg heating using a portable sauna blanket up to the hip (temperature of the blanket will be set at 65°C, 4 times/week, 45 min/session), whereas women in the control group will set the temperature of the blanket at 35°C at the same frequency and duration. Participants will be evaluated at baseline and then at 28-30 weeks of gestation. Aim 1 will determine the effects of chronic leg heating on maternal vascular function and surrogate markers of HDP. Aim 2 will determine the effects of chronic leg heating on sympathetic vasoconstriction and BP. Findings from this project will provide insight on the extent and potential mechanisms of how chronic leg heating works for improving vascular endothelial function and sympathetic vasoconstriction in pregnant women with obesity. Results obtained will set a foundation for future large multicenter clinical trials to determine the efficacy and generalizability of home-based leg heat therapy as a safe, ease-of-use, cost-effective, and non-drug approach for reducing the risk of HDP.

CONDITIONS

Official Title

Leg Heating in Pregnant Women With Obesity

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 45 years
  • Pregnant between 10 and 14 weeks of gestation
  • Self-reported pre-pregnancy body mass index of 25 kg/m2 or higher
  • Both normotensive and hypertensive (systolic BP 140-150 mmHg and/or diastolic BP 90-100 mmHg) if not on antihypertensive drugs
  • Nulliparous and multiparous women
  • No restrictions on race, ethnicity, or socioeconomic status
  • Women with a history of hypertensive disorders of pregnancy allowed
  • Women taking low-dose aspirin allowed with documentation
Not Eligible

You will not qualify if you...

  • Current multiple pregnancies (e.g., twins or more)
  • Known major fetal chromosomal or anatomical abnormalities diagnosed during the study
  • History of recurrent miscarriage (three or more)
  • Office sitting blood pressure below 100/55 mmHg or above 150/100 mmHg
  • Evidence of cardiovascular, pulmonary, or neurological diseases
  • Diagnosis of diabetes mellitus
  • Kidney disease with serum creatinine above 0.9 mg/dL
  • Known deep vein thrombosis or related symptoms or skin lesions
  • History of drug or alcohol abuse within the last 2 years
  • Current tobacco use
  • Lack of air conditioning at home during summer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine

Dallas, Texas, United States, 75231

Actively Recruiting

Loading map...

Research Team

Q

Qi Fu, MD, PhD

CONTACT

M

Monique Roberts-Reeves, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here