- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Ontario
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Toronto, Ontario, Kanada, M5G1X5
- Mount Sinai Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
|
30-60 mg, twice daily
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Systemic vascular resistance
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Maximum change in maternal blood pressure
Časové okno: 20-22, 24-26, 28, 30-32 and 36 weeks gestational age
|
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
|
|
Gestational age at delivery
Časové okno: 25-41 weeks gestational age
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25-41 weeks gestational age
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|
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Fetal weight at delivery
Časové okno: 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
Časové okno: 25-41 weeks gestational age
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25-41 weeks gestational age
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|
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Gestational age at peak maternal blood pressure
Časové okno: 20-41 weeks
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20-41 weeks
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|
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Gestational age at which steroids are administered
Časové okno: 25-41 weeks gestational age
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25-41 weeks gestational age
|
|
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Serum s-Flt and PlGF levels
Časové okno: 12-41 weeks gestational age
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12-41 weeks gestational age
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Kardiovaskulární choroby
- Cévní onemocnění
- Těhotenské komplikace
- Hypertenze vyvolaná těhotenstvím
- Hypertenze
- Eklampsie
- Preeklampsie
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Vazodilatační činidla
- Membránové transportní modulátory
- Hormony a látky regulující vápník
- Činidla pro kontrolu reprodukce
- Blokátory vápníkových kanálů
- Tokolytická činidla
- Nifedipin
Další identifikační čísla studie
- 10-03
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