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OpenTrials
Completed

NCT Number: NCT01861132

Validation of a Non-invasive Hemodynamic Monitor (NexFin) in Pregnant Women

Blood pressure and cardiac output can be measured invasively in pregnant women. Non-invasive monitoring devices are desirable, but until now, no equipment has proven validity. This study aims at validating the non-invasive monitoring device NexFin (second generation Finometer) in pregnant women.

Completed

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Key information

Conditions

Hemodynamic Changes in Pregnancy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0424, Norway

About this study

Validation will be a direct beat-to-beat comparison of data from NexFin and the invasive measurements of blood pressure and calibrated cardiac output as an integrated part of LiDCO Plus. Both comparison of absolute values and the two different devices trending abilities will be analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy singleton pregnancies at term scheduled for cesarean delivery

Exclusion criteria

  • Twins, or multiple gestation, pre-eclampsia, gestational hypertension
  • Reynaud phenomenon

Treatment and study plan

Primary outcomes

  1. Systolic blood pressure

    Time frame: 15 minutes

    Comparison of beat-to-beat data

Secondary outcomes

  1. Cardiac output

    Time frame: 15 minutes

    Comparing beat-to-beat data of cardiac output

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Validation of Non-invasive Monitoring of Blood Pressure and Cardiac Output in Healthy Pregnant Women During Cesarean Section

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 23, 2013
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.