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Hemodynamic Assessment of Healthy and Hypertensive Pregnant Women by Non-Invasive Bio-Reactance

25. marts 2010 opdateret af: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Hemodynamic Assessment of Healthy and Hypertensive Pregnant Women by Non-invasive Bio-reactance

The purpose of this study is to determine whether a noninvasive method of measuring certain aspects of blood circulation (e.g., blood pressure, cardiac output) is an accurate and reliable method to detect changes in pregnant patients. Specifically,the investigators are interested in patients diagnosed with high blood pressure during their pregnancy, as compared with normal pregnant patients. A noninvasive, accurate method of taking these measurements in pregnant patients is not currently available.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X5
        • Mount Sinai Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Our study population includes healthy non-pregnant and pregnant patients in their 3rd trimester, as well as pregnant patients in their 3rd trimester with pregnancy-induced hypertension (PIH). Both normal groups will be recruited from the outpatient day-unit (healthy volunteers). Patients with PIH may be sent to labour and delivery for monitoring by their obstetricians.

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Normal, Non-Pregnant
Normal, non-pregnant patients will have 15 minutes of monitoring at rest, followed by a passive leg raising test.
Normal, Pregnant
Normal, pregnant patients in their 3rd trimester will have 15 minutes of monitoring at rest, followed by a passive leg raising test.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Cardiac Index (CI)
Tidsramme: 20 minutes
20 minutes

Sekundære resultatmål

Resultatmål
Tidsramme
Cardiac Output (CO)
Tidsramme: 20 minutes
20 minutes
Blood Pressure (BP)
Tidsramme: 20 minutes
20 minutes
Systemic Vascular Resistance (SVR)
Tidsramme: 20 minutes
20 minutes

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2009

Primær færdiggørelse (Faktiske)

1. december 2009

Studieafslutning (Faktiske)

1. december 2009

Datoer for studieregistrering

Først indsendt

29. juli 2009

Først indsendt, der opfyldte QC-kriterier

29. juli 2009

Først opslået (Skøn)

30. juli 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. marts 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. marts 2010

Sidst verificeret

1. marts 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 09-01

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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