- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01351428
Goal-Directed Therapy in Pregnant Women at High Risk of Developing Preeclampsia
Non-invasive Hemodynamic Monitoring and Goal-Directed Therapy in Pregnant Women at High Risk of Developing Preeclampsia
Preeclampsia is associated with significant maternal and fetal morbidity and mortality. Early identification and subsequent management of patients at risk of developing preeclampsia presents an ongoing challenge in prenatal care. Some at risk pregnancies may be identified from:
- serum screening abnormalities in the first or second trimester
- placental shape and texture at the 18-20 anatomical ultrasound
- uterine artery blood flow.
Early identification and effective treatment of patients would permit the safe completion of the pregnancy for the mother and infant. Recent advances in non-invasive cardiovascular monitoring have enabled the study of maternal hemodynamics in normal and at-risk pregnancies. This study hopes to identify the earliest significant changes in maternal hemodynamics which may allow targeted therapeutic interventions in patients at high risk of developing preeclampsia.
The hypothesis of this study is that systemic vascular resistance rises during the pre-clinical phase of preeclampsia and this can be captured using non invasive bioreactance technology. Treatment of the abnormally high vascular tone may decrease the severity and postpone the onset of clinical disease.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Invasive hemodynamic techniques have long identified significant increases in heart rate (HR), blood volume, left ventricular end-diastolic volume (LVEDV), stroke volume (SV) and cardiac output (CO) during the first and second trimesters of pregnancy. In normal pregnancy, CO increases from as early as 5 weeks gestation, with a 30-40% increase by the end of the first trimester of pregnancy. Cardiac output continues to rise throughout the second trimester until it reaches a level approximately 50% greater than that of non-pregnant women. Cardiac output slightly decreases during the third trimester. Despite these changes, maternal blood pressure (BP) still falls due to a large reduction in systemic vascular resistance (SVR) from systemic vasodilatation and the formation of a low-resistance utero-placental circulation. Systemic vascular resistance falls during early gestation, reaching its nadir (35% decline) at 20 weeks gestation, and rises during late pregnancy.
Transthoracic bioreactance is a newer technique of non-invasive continuous cardiac output monitoring. It is based on an analysis of relative phase shifts of oscillating currents that occur when this current traverses the thoracic cavity, as opposed to the traditional bioimpedance-based system, which rely only on measured changes in signal amplitude. Unlike bioimpedance, bioreactance-based non-invasive CO measurement does not use the static impedance and does not depend on the distance between the electrodes for the calculations of SV and CO, which significantly reduces the uncertainty in the result. Moreover, its readings were shown to correlate well with results derived from pulmonary artery catheter derived measurement of cardiac output. In addition, it has also been shown that the non-invasive cardiac output measurement (NICOM®) system has acceptable accuracy, precision and responsiveness for CO monitoring in patients experiencing a wide range of circulatory situations and has recently been used in the obstetric population.
The purpose of this study is to use non-invasive cardiac output monitoring to capture the earliest inappropriate rise in SVR during the pre clinical phase of disease, in patients at high risk of developing preeclampsia, as predicted by the placenta profile. In case an increase in SVR is identified, the purpose of this study is to implement a goal-directed therapy in an attempt to decrease the severity, and postpone the onset of clinical disease.
The hypothesis of this study is that the increases in SVR detected during the pre-clinical phase of preeclampsia can be treated with a goal directed therapy without fetal compromise and that this intervention may improve maternal and fetal/neonatal outcome.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Ontario
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Toronto, Ontario, Canadá, M5G1X5
- Mount Sinai Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Risk factors for preeclampsia/IUGR - medical or obstetric
- Abnormal uterine artery Doppler
- Two of the following:
Abnormal placental biochemistry Abnormal placental shape Abnormal placental texture
Exclusion Criteria:
- Multifetal pregnancy
- Fetal abnormality, including nuchal translucency more than 3mm at 12 weeks
- Preterm labor/pprom/bleeding/rescue cerclage (excluding elective 12 week prophylactic cerclage)
- Type 1 diabetes mellitus
- Heparin use
- Chronic hypertension on treatment before 20 weeks
- Documented chronic renal disease
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: NICOM group
Vasodilator therapy begins when SVR increases by 20% or greater than baseline.
Therapy is titrated according to hemodynamic profile and clinical signs and symptoms.
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30-60 mg, twice daily
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Systemic vascular resistance
Prazo: 20-22, 24-26, 28, 30-32 and 36 weeks gestational age
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Systemic vascular resistance is measured at the above time points, and more frequently at the discretion of the attending obstetrician.
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20-22, 24-26, 28, 30-32 and 36 weeks gestational age
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Maximum change in maternal blood pressure
Prazo: 20-22, 24-26, 28, 30-32 and 36 weeks gestational age
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Blood pressure is taken on the NICOM at the above time points, and more frequently at obstetric appointments in between.
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20-22, 24-26, 28, 30-32 and 36 weeks gestational age
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Gestational age at delivery
Prazo: 25-41 weeks gestational age
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25-41 weeks gestational age
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Fetal weight at delivery
Prazo: 25-41 weeks gestational age
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25-41 weeks gestational age
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Gestational age at time of first hospitalization
Prazo: 25-41 weeks gestational age
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25-41 weeks gestational age
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Gestational age at peak maternal blood pressure
Prazo: 20-41 weeks
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20-41 weeks
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Gestational age at which steroids are administered
Prazo: 25-41 weeks gestational age
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25-41 weeks gestational age
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Serum s-Flt and PlGF levels
Prazo: 12-41 weeks gestational age
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12-41 weeks gestational age
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Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças cardiovasculares
- Doenças Vasculares
- Complicações na Gravidez
- Hipertensão Induzida pela Gravidez
- Hipertensão
- Eclampsia
- Pré-eclâmpsia
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Vasodilatadores
- Moduladores de transporte de membrana
- Hormônios e Agentes Reguladores de Cálcio
- Agentes de Controle Reprodutivo
- Bloqueadores dos Canais de Cálcio
- Tocolíticos
- Nifedipina
Outros números de identificação do estudo
- 10-03
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