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NCT06932250 · ClinicalTrials.gov registry record · NA
Leg Heating in Pregnant Women With Obesity
A NA study of High Risk Pregnancy, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 118
- Enrollment target
- 1
- Study location
NCT06932250: Recruiting NA study of High Risk Pregnancy, sponsored by University of Texas Southwestern Medical Center.
NCT06932250 is a NA study of High Risk Pregnancy that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 118 participants, below the 316-participant average among 10 other High Risk Pregnancy trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06932250, a NA study of High Risk Pregnancy, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 118 participants
- Enrollment target
- 1
- Study location
Study 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 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 heat
Primary Outcome
Change in vascular endothelial function assessed by brachial artery flow-mediated vasodilation using the Doppler ultrasound technique
Conditions Studied
Interventions
- OTHER Leg heating
Study Locations (1)
Texas
- UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2025-05-01 |
| Est. Completion | 2030-04-30 |
| Phase | NA |
What NCT06932250 shows while recruiting
NCT06932250 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 316-participant average among 10 other High Risk Pregnancy trials with a reported enrollment target (63% lower).
The record links to 1 condition, with High Risk Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which Leg heating is the first listed.
NCT06932250 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06932250 about?
NCT06932250 is a clinical study titled "Leg Heating in Pregnant Women With Obesity". 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) path...
What is the current status of trial NCT06932250?
This trial is currently recruiting. It is a NA study. The enrollment target is 118 participants. The study started on 2025-05-01. Estimated completion is 2030-04-30.
What conditions does trial NCT06932250 study?
This clinical trial studies the following conditions: High Risk Pregnancy.
What interventions are being tested in trial NCT06932250?
The interventions under investigation include: Leg heating (OTHER).
Who is sponsoring clinical trial NCT06932250?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06932250 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06932250's enrollment target sits among peer trials
118 7th of 10 higher than 4 of 10 other High Risk Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High Risk Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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