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
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5G1X5
- Mount Sinai Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Cardiac Index (CI)
Tidsramme: 20 minutes
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20 minutes
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Cardiac Output (CO)
Tidsramme: 20 minutes
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20 minutes
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Blood Pressure (BP)
Tidsramme: 20 minutes
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20 minutes
|
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Systemic Vascular Resistance (SVR)
Tidsramme: 20 minutes
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20 minutes
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 09-01
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