Leg heating for pregnant women with overweight or obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Women with pre-pregnancy BMI ≥25 and gestational age 10–14 weeks will receive repeated regional leg heating sessions to test effects on maternal vascular function. The intervention aims to increase nitric oxide availability, reduce endothelin-1, and blunt sympathetic vasoconstriction—mechanisms linked to hypertensive disorders of pregnancy. Investigators will measure endothelial function, blood pressure, and markers of sympathetic activity and vasoactive pathways before and after the intervention. The approach is intended as a low-cost, well-tolerated, non-exercise alternative to improve vascular health during pregnancy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

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).

Where it's running

• UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Qi Fu, MD, PhD — UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine
• Study coordinator: Qi Fu, MD, PhD
• Email: QiFu@TexasHealth.org
• Phone: 214-345-8125

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.