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โ† Trials
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Leg Heating in Pregnant Women With Obesity

RecruitingNAAges 18 Years - 45 YearsFemaleUniversity of Texas Southwestern Medical Center
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Women with overweight or obesity (self-reported pre-pregnancy body mass index โ‰ฅ25 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 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). * 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).
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What it tests

  • Leg heating
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Where

1 site
UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine
Dallas, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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