Up-Down Determination of the ED90 of Phenylephrine for Hypotension Prophylaxis in Cesarean Delivery

This study has been terminated.
(Results Invalid, study closed, analysis cannot proceed.)
Sponsor:
Information provided by (Responsible Party):
Ronald George, IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00796328
First received: November 19, 2008
Last updated: September 3, 2014
Last verified: September 2014
Results First Received: March 14, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Spinal Induced Hypotension in Cesarean Delivery
Intervention: Drug: Phenylephrine infusion

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Six subjects were withdrawn from the study

Reporting Groups
  Description
Phenylephrine Infusion Phenylephrine infusion : Up-down, biased coin design

Participant Flow:   Overall Study
    Phenylephrine Infusion  
STARTED     46  
COMPLETED     40  
NOT COMPLETED     6  
experienced hypotension requiring tx                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Phenylephrine Infusion Phenylephrine infusion : Up-down, biased coin design

Baseline Measures
    Phenylephrine Infusion  
Number of Participants  
[units: participants]
  46  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     46  
>=65 years     0  
Gender  
[units: participants]
 
Female     46  
Male     0  



  Outcome Measures

1.  Primary:   Effective Dose of Phenylephrine at Which 90% of Subjects Have no Spinal Induced Hypotension   [ Time Frame: Spinal administration until delivery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Ron George
Organization: IWK Health Centre
phone: 470-6627
e-mail: rbgeorge@dal.ca


No publications provided


Responsible Party: Ronald George, IWK Health Centre
ClinicalTrials.gov Identifier: NCT00796328     History of Changes
Other Study ID Numbers: IWK-4462-2008
Study First Received: November 19, 2008
Results First Received: March 14, 2014
Last Updated: September 3, 2014
Health Authority: Canada: Ethics Review Committee