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Evaluation of NEXFIN During Cesarean Delivery to Detect Hypotension (NEXFIN-CESAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01732133
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:
Hypotension after spinal anesthesia for cesarean delivery occurs frequently. Oscillometric measurement gives intermittent informations. Nexfin, a continuous noninvasive device, could help to detect hypotension.

Condition or disease Intervention/treatment Phase
Hypotension Device: Nexfin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the System NEXFIN for Continuous and Non-invasive Measure of the Blood Pressure During Cesarean Delivery Practised Under Spinal Anesthesia
Actual Study Start Date : April 2013
Actual Primary Completion Date : January 22, 2016
Actual Study Completion Date : January 22, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Measurement of arterial pressure Device: Nexfin
Other Name: Continuous measurement of arterial pressure using Nexfin

Primary Outcome Measures :
  1. Comparison between Nexfin and intermittent measurements of blood pressure [ Time Frame: two years ]
    Bland and Altman analysis (bias and limits of agreement). Analysis concerns data from intrathecal injection to childbirth

Secondary Outcome Measures :
  1. Area under the curve between both measurements [ Time Frame: two years ]
    Analysis concerns data from intrathecal injection to childbirth

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients undergoing elective cesarean delivery performed under spinal anesthesia

Exclusion Criteria:

  • patients with a heart rhythm disorder, Raynaud's disease or a history of vascular surgery of the upper limb

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01732133

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Institut Hospitalier Franco-Britannique
Levallois, France, 92300
Hopital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch
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Study Chair: Marc Fischler, MD Hopital Foch
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Responsible Party: Hopital Foch Identifier: NCT01732133    
Other Study ID Numbers: 2012/27
2012-A00811-42 ( Other Identifier: ANSM )
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Keywords provided by Hopital Foch:
Cesarean delivery
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases