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Clinical Trial NCT06932250 for High-risk Pregnancy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Leg Heating in Pregnant Women With Obesity 118 Home-Based Pregnancy

Recruiting
Clinical Trial NCT06932250 is an interventional study for High-risk Pregnancy that is recruiting. It started on 1 May 2025 with plans to enroll 118 participants. Led by University of Texas Southwestern Medical Center, it is expected to complete by 30 April 2030. The latest data from ClinicalTrials.gov was last updated on 2 March 2026.
Brief Summary
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...Show More
Detailed Description
Obesity is a major risk factor for hypertensive disorders of pregnancy (HDP). The underlying mechanisms are unclear, but maternal vascular endothelial dysfunction is likely involved. Endothelial dysfunction in HDP could be attributed in part to: 1) alterations in the L-arginine/nitric oxide (NO) pathway, and 2) an increase in endothelin-1 (ET-1). Conversely, augmented sympathetic vasoconstriction may also contribute ...Show More
Official Title

Vascular and Neural Mechanisms of Chronic Leg Heating in Pregnant Women With Obesity

Conditions
High-risk Pregnancy
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • STU20250500
NCT ID Number
NCT06932250
Start Date (Actual)
2025-05-01
Last Update Posted
2026-03-02
Completion Date (Estimated)
2030-04-30
Enrollment (Estimated)
118
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Pregnancy
Obesity
Heat therapy
Vascular function
Sympathetic neural control
Blood pressure
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSauna blanket set at 65°C
The temperature of the sauna blanket will be set at 65°C and participants will perform home-based leg heating 4 times per week, 45 minutes per session.
Leg heating
Participants will perform home-based leg heating using a portable sauna blanket set at different temperature.
Placebo ComparatorSauna blanket set at 35°C
The temperature of the sauna blanket will be set at 35°C and participants will perform home-based leg heating 4 times per week, 45 minutes per session.
Leg heating
Participants will perform home-based leg heating using a portable sauna blanket set at different temperature.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in vascular endothelial function
Change in vascular endothelial function assessed by brachial artery flow-mediated vasodilation using the Doppler ultrasound technique
Baseline, 16 weeks after leg heating
Change in sympathetic neural control
Change in sympathetic neural control assessed by muscle sympathetic nerve (re)activity using the microneurographic technique
Baseline, 16 weeks after leg heating
Change in sympathetic vascular transduction
Change in sympathetic vascular transduction assessed using the microneurographic and Doppler ultrasound techniques
Baseline, 16 weeks after leg heating
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in blood concentration of nitrate
Blood concentration of nitrate will be used to estimate nitric oxide bioavailability
Baseline, 16 weeks after leg heating
Change in blood concentration of nitrite
Blood concentration of nitrite will be used to estimate nitric oxide bioavailability
Baseline, 16 weeks after leg heating
Change in L-arginine level
Baseline, 16 weeks after leg heating
Change in asymmetric dimethylarginine level
Baseline, 16 weeks after leg heating
Change in 3-nitrotyrosine level
Baseline, 16 weeks after leg heating
Change in concentration of endothelin-1
Baseline, 16 weeks after leg heating
Change in 24-hour ambulatory blood pressure
Baseline, 16 weeks after leg heating
Change in placental growth factor level
Baseline, 16 weeks after leg heating
Change in solube fms-like tyrosine kinase-1 level
Baseline, 16 weeks after leg heating
Change in soluble endoglin level
Baseline, 16 weeks after leg heating
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
  • 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.

  • 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).
University of Texas Southwestern Medical Center logoUniversity of Texas Southwestern Medical Center
Study Responsible Party
Qi Fu, Principal Investigator, Professor, University of Texas Southwestern Medical Center
Study Central Contact
Contact: Qi Fu, MD, PhD, 214-345-8125, [email protected]
Contact: Monique Roberts-Reeves, RN, 214-345-4656, [email protected]
1 Study Locations in 1 Countries

Texas

UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine, Dallas, Texas, 75231, United States
Monique Roberts-Reeves, RN, Contact, 214-345-4656, [email protected]
Recruiting