- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00949260
Hemodynamic Assessment of Healthy and Hypertensive Pregnant Women by Non-Invasive Bio-Reactance
Hemodynamic Assessment of Healthy and Hypertensive Pregnant Women by Non-invasive Bio-reactance
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
During pregnancy, many aspects of blood circulation, such as blood pressure, heart rate, cardiac output, and stroke volume, adapt to accommodate the increasing needs of a pregnant body. The circulatory system works harder to provide blood flow to the placenta and the growing fetus.
Currently, the devices that can give physicians detailed information on the status of the blood circulation of normal patients and those with high blood pressure during pregnancy are invasive to varying degrees. However, recently, a new noninvasive hemodynamic monitor (NonInvasive Cardiac Output Monitoring: NICOM) was introduced to the market. In studies with non-pregnant patients, the NICOM has been found to be accurate, precise and reliable. However, it has yet to be studied in the field of Obstetrics.
The purpose of this study is to find out if the NICOM is an effective tool for monitoring hemodynamic changes in pregnant women, both with normal and high blood pressure. We are planning to compare the hemodynamic profiles of normal pregnant patients, hypertensive pregnant patients, and non pregnant patients as a control group. If this monitor proves to be reliable in assessing these changes in the pregnant patients, this could have a great impact in optimizing the care of the patients with different medical conditions in pregnancy, such as increased blood pressure.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Ontario
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Toronto, Ontario, Kanada, M5G1X5
- Mount Sinai Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- PIH diagnosed in 3rd trimester, not yet treated
- healthy pregnant patients in 3rd trimester
- healthy non-pregnant women
Exclusion Criteria:
- under age 18 or above age 40
- refusal to participate
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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Normal, Non-Pregnant
Normal, non-pregnant patients will have 15 minutes of monitoring at rest, followed by a passive leg raising test.
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Normal, Pregnant
Normal, pregnant patients in their 3rd trimester will have 15 minutes of monitoring at rest, followed by a passive leg raising test.
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Pregnant, PIH
Pregnant patients in their 3rd trimester with pregnancy-induced hypertension that has not been treated will have 15 minutes of monitoring at rest, followed by a passive leg raising test.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Cardiac Index (CI)
Tidsram: 20 minutes
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20 minutes
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Cardiac Output (CO)
Tidsram: 20 minutes
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20 minutes
|
|
Blood Pressure (BP)
Tidsram: 20 minutes
|
20 minutes
|
|
Systemic Vascular Resistance (SVR)
Tidsram: 20 minutes
|
20 minutes
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 09-01
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