Status:
RECRUITING
Leg Heating in Pregnant Women With Obesity
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
High-risk Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
NA
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. Endotheli...
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 dysfu...
Eligibility Criteria
Inclusion
- Women with obesity (self-reported pre-pregnancy body mass index ≥30 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)42 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
- 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).
- Severe sleep apnea (an apnea-hypopnea index ≥30 events/h43 based on the results from in-home sleep testing) or previously diagnosed and treated sleep apnea.
- Evidence of cardiovascular, pulmonary, or neurological diseases.
- Diabetes mellitus or a history of gestational diabetes (to avoid its effects on vascular endothelial function and sympathetic vasoconstriction).
- Kidney disease (serum creatinine \>0.9 mg/dL).44, 45
- 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).
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2030
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT06932250
Start Date
May 1 2025
End Date
May 31 2030
Last Update
September 25 2025
Active Locations (1)
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1
UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine
Dallas, Texas, United States, 75231