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O estudo clínico NCT06932250 para High-risk Pregnancy está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Centro Médico Sudoeste da Universidade do TexasLeg Heating in Pregnant Women With Obesity 118 Domiciliar Gestantes
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06932250 é um estudo intervencionista para High-risk Pregnancy. Seu status atual é: em recrutamento. O estudo começou em 1 de maio de 2025 e pretende incluir 118 participantes. Coordenado por o Centro Médico Sudoeste da Universidade do Texas e deve ser concluído em 30 de abril de 2030. Essas informações foram atualizadas no ClinicalTrials.gov em 2 de março de 2026.
Resumo
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...Mostrar mais
Descrição detalhada
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 dysfunction in HDP could be attributed in part to: 1) alterations in the L-arginine/nitric oxide (NO) pathway, and 2) an increase in endothelin-1 (ET-1). Conversely, augmented sympathetic vasoconstriction may also contribute ...Mostrar mais
Título oficial
Vascular and Neural Mechanisms of Chronic Leg Heating in Pregnant Women With Obesity
Condições médicas
High-risk PregnancyPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- STU20250500
Número NCT
Data de início (real)
2025-05-01
Última atualização postada
2026-03-02
Data de conclusão (estimada)
2030-04-30
Inscrição (estimada)
118
Tipo de estudo
Intervencionista
FASE
N/A
Status
Em recrutamento
Palavras-chave
Pregnancy
Obesity
Heat therapy
Vascular function
Sympathetic neural control
Blood pressure
Obesity
Heat therapy
Vascular function
Sympathetic neural control
Blood pressure
Propósito principal
Outro
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Cego simples
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalSauna blanket set at 65°C The temperature of the sauna blanket will be set at 65°C and participants will perform home-based leg heating 4 times per week, 45 minutes per session. | Leg heating Participants will perform home-based leg heating using a portable sauna blanket set at different temperature. |
Comparador placeboSauna blanket set at 35°C The temperature of the sauna blanket will be set at 35°C and participants will perform home-based leg heating 4 times per week, 45 minutes per session. | Leg heating Participants will perform home-based leg heating using a portable sauna blanket set at different temperature. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Change in vascular endothelial function | Change in vascular endothelial function assessed by brachial artery flow-mediated vasodilation using the Doppler ultrasound technique | Baseline, 16 weeks after leg heating |
Change in sympathetic neural control | Change in sympathetic neural control assessed by muscle sympathetic nerve (re)activity using the microneurographic technique | Baseline, 16 weeks after leg heating |
Change in sympathetic vascular transduction | Change in sympathetic vascular transduction assessed using the microneurographic and Doppler ultrasound techniques | Baseline, 16 weeks after leg heating |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Change in blood concentration of nitrate | Blood concentration of nitrate will be used to estimate nitric oxide bioavailability | Baseline, 16 weeks after leg heating |
Change in blood concentration of nitrite | Blood concentration of nitrite will be used to estimate nitric oxide bioavailability | Baseline, 16 weeks after leg heating |
Change in L-arginine level | Baseline, 16 weeks after leg heating | |
Change in asymmetric dimethylarginine level | Baseline, 16 weeks after leg heating | |
Change in 3-nitrotyrosine level | Baseline, 16 weeks after leg heating | |
Change in concentration of endothelin-1 | Baseline, 16 weeks after leg heating | |
Change in 24-hour ambulatory blood pressure | Baseline, 16 weeks after leg heating | |
Change in placental growth factor level | Baseline, 16 weeks after leg heating | |
Change in solube fms-like tyrosine kinase-1 level | Baseline, 16 weeks after leg heating | |
Change in soluble endoglin level | Baseline, 16 weeks after leg heating |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto
Idade mínima
18 Years
Sexos elegíveis
Feminino
Aceita voluntários saudáveis
Sim
- 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.
- 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).
Centro Médico Sudoeste da Universidade do TexasResponsável pelo estudo
Qi Fu, Investigador principal, Professor, University of Texas Southwestern Medical Center
Contato central do estudo
Contato: Qi Fu, MD, PhD, 214-345-8125, [email protected]
Contato: Monique Roberts-Reeves, RN, 214-345-4656, [email protected]
1 Locais do estudo em 1 países
Texas
UT Southwestern Medical Center; Institute for Exercise and Environmental Medicine, Dallas, Texas, 75231, United States
Monique Roberts-Reeves, RN, Contato, 214-345-4656, [email protected]
Em recrutamento