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Continuous Labor Epidural Catheter for Tubal Ligation Study

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Marsha Wakefield, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00898443
First received: May 8, 2009
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
Results First Received: April 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Conditions: Tubal Ligation
Bilateral Tubal Ligation
Interventions: Other: Epidural anesthetic
Other: Spinal anesthetic

  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
Women in labor, admitted to UAB Labor & Delivery, who requested postpartum tubal ligation after delivery.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Spinal Anesthetic Group This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
Epidural Anesthetic Group This is the experimental group for this study.

Participant Flow:   Overall Study
    Spinal Anesthetic Group     Epidural Anesthetic Group  
STARTED     10     8  
COMPLETED     9     8  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Spinal Anesthetic Group This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
Epidural Anesthetic Group This is the experimental group for this study.
Total Total of all reporting groups

Baseline Measures
    Spinal Anesthetic Group     Epidural Anesthetic Group     Total  
Number of Participants  
[units: participants]
 		  9     8     17  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     9     8     17  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     9     8     17  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     9     8     17  



  Outcome Measures
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1.  Primary:   Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation   [ Time Frame: at the time of surgery ]
  Show Outcome Measure 1

2.  Secondary:   Impact of Anesthesia Type on OR (Operating Room) Efficiency   [ Time Frame: minutes until surgery start ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Marsha Wakefield, M.D.
Organization: UAB
phone: 205-934-4696
e-mail: mwakefield@uab.edu


No publications provided


Responsible Party: Marsha Wakefield, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00898443     History of Changes
Other Study ID Numbers: F080829007
Study First Received: May 8, 2009
Results First Received: April 19, 2012
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board