118 Participants Needed

Leg Heating for Complicated Pregnancy

MR
QF
Overseen ByQi Fu, MD, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using a sauna blanket to heat the legs can improve blood vessel function and lower blood pressure in pregnant women with obesity. The aim is to determine if this simple, at-home treatment can reduce the risk of high blood pressure disorders during pregnancy. Participants will be divided into two groups: one using a blanket heated to 65°C and another at a lower temperature of 35°C for comparison. Women who are pregnant between 10-14 weeks, have obesity, and are not on certain medications may be eligible to join. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to new, accessible treatments for pregnant women.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on antihypertensive drugs. You can continue taking low-dose aspirin if you are already using it.

What prior data suggests that leg heating is safe for pregnant women with obesity?

Research has shown that using heat therapy, such as a heating pad, is generally safe during pregnancy if it doesn't significantly raise body temperature. One study found that heat therapy can reduce labor pain and shorten labor, suggesting potential benefits. However, using saunas during pregnancy is usually not recommended, as high body temperatures can lead to complications or birth defects.

In this trial, researchers use a sauna blanket set to a specific temperature to warm the legs. While the benefits of heat therapy are evident, maintaining a safe body temperature is crucial to avoid risks. This trial aims to determine if this specific method is safe and effective for pregnant women with obesity.12345

Why are researchers excited about this trial?

Unlike traditional treatments for complicated pregnancies, which often involve medications or surgical interventions, this new approach uses leg heating through a sauna blanket. Researchers are excited about this treatment because it offers a non-invasive and potentially safer method to improve circulation and reduce pregnancy complications. By setting the sauna blanket at 65°C, the therapy aims to provide therapeutic warmth that can be performed easily at home, promoting relaxation and enhanced blood flow without the need for drugs. This innovative method could offer a new way to support maternal health with fewer side effects.

What evidence suggests that leg heating might be an effective treatment for hypertensive disorders of pregnancy?

Research has shown that regular heat exposure can improve blood vessel health. Heat increases nitric oxide, which aids blood flow, and reduces endothelin-1, which can constrict blood vessels. These changes can enhance blood vessel function and lower blood pressure. Some studies suggest that heat therapy might reduce labor pain and duration for pregnant women, although most research has focused on non-pregnant individuals. In this trial, participants will be assigned to different arms to test the effects of leg heating. One arm will use a sauna blanket set at 65°C, while another will use a sauna blanket set at 35°C. The researchers aim to determine if applying heat to the legs can help manage blood vessel problems related to high blood pressure during pregnancy. This could be particularly beneficial for pregnant women with obesity, who face a higher risk for these issues.15678

Who Is on the Research Team?

QF

Qi Fu, MD, PhD

Principal Investigator

UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine

Are You a Good Fit for This Trial?

This trial is for pregnant women with obesity, between 12-14 weeks of gestation. It aims to see if leg heating can reduce the risk of hypertensive disorders during pregnancy by improving blood vessel function and reducing overactive sympathetic nerves.

Inclusion Criteria

Both nulliparous and multiparous women will be enrolled
No restriction regarding race/ethnicity and socioeconomic status
I am an overweight woman, pregnant between 10-14 weeks, aged 18-45.
See 3 more

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)
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform home-based leg heating using a portable sauna blanket set at 65°C or 35°C, 4 times per week, 45 minutes per session

16 weeks
Baseline and 28-30 weeks of gestation evaluations

Follow-up

Participants are monitored for changes in vascular endothelial function and sympathetic vasoconstriction

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Leg Heating
Trial Overview The study tests whether home-based leg heating using a sauna blanket can benefit vascular health in obese pregnant women. Participants are randomly assigned to either heat their legs at 65°C or use a control setting at 35°C, four times a week for 45 minutes over 16 weeks.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sauna blanket set at 65°CExperimental Treatment1 Intervention
Group II: Sauna blanket set at 35°CPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Citations

effect-of-stretching-exercises-versus-thermotherapy-on- ...Hanafy and Gbr (2018) claimed that the effectiveness of stretching exercises could be complemented with continuous ultrasounds heating before moving pregnant.
Sauna Use During Pregnancy: What to KnowSauna use during pregnancy can improve circulation, support detoxification, and provide relief from aches and pains. However, there are risks involved.
Leg Heating for Complicated PregnancyThe investigators' central hypothesis is that chronic leg heating will be effective in improving vascular endothelial function and attenuating sympathetic ...
NCT06932250 | Leg Heating in Pregnant Women With ObesityFindings from this project will provide insight on the extent and potential mechanisms of how chronic leg heating works for improving vascular endothelial ...
The effect of heat therapy on pain intensity, duration ...Current evidence shows that heat therapy effectively decreases labor pain intensity and shortens the duration of labor in the first stage.
Saunas During PregnancyBut it's best to avoid the sauna during pregnancy because high body temperatures can increase the risk of complications or birth defects. Pregnant women are ...
Heating pad while pregnant: Benefits and risksIt is safe to use heating pads during pregnancy so long as they do not raise the body temperature too much. Heating pads can soothe the many aches and pains ...
Sauna During Pregnancy: Risks, Myths & Safety TipsIf you have high-risk pregnancy conditions: Avoid it! For women who have high-risk pregnancies with conditions like preeclampsia ...
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