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The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery

This study has been completed.
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00443560
First received: March 2, 2007
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
Results First Received: May 9, 2011  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Retrospective
Conditions: Labor Pain
Pregnancy
Intervention: Other: Case controlled analysis of epidural labor analgesia patterns

  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
The Obstetric Anesthesiology Database was used to identify parturients from the Labor and Delivery Unit of Prentice Women's Hospital of Northwestern Memorial Hospital who qualified for the study between January 2004 and October 2005.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Instrumental Vaginal Delivery (IVD) Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
Spontaneous Vaginal Delivery (SVD) The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.

Participant Flow:   Overall Study
    Instrumental Vaginal Delivery (IVD)     Spontaneous Vaginal Delivery (SVD)  
STARTED     1081     1081  
COMPLETED     1021     1051  
NOT COMPLETED     60     30  
No intrathecal dose                 58                 26  
Multiple pregnancies or fetal demise                 2                 4  



  Baseline Characteristics
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Reporting Groups
  Description
Instrumental Vaginal Delivery (IVD) Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
Spontaneous Vaginal Delivery (SVD) The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
Total Total of all reporting groups

Baseline Measures
    Instrumental Vaginal Delivery (IVD)     Spontaneous Vaginal Delivery (SVD)     Total  
Number of Participants  
[units: participants]
 		  1081     1081     2162  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     1081     1081     2162  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  32  ± 3     31  ± 3     31  ± 3  
Gender  
[units: participants]
 		     
Female     1081     1081     2162  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     1081     1081     2162  



  Outcome Measures
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1.  Primary:   Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor   [ Time Frame: Second stage of labor up to 3 hours ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Breakthrough Pain in the First Stage of Labor   [ Time Frame: Supplemental analgesia in first stage of labor (<24 hours) ]
  Show Outcome Measure 2

3.  Secondary:   Duration of Labor Analgesia   [ Time Frame: Time form initiation of labor analgesia to delivery (up to 24 hours) ]
  Show Outcome Measure 3


  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
The retrospective design incurs the risk of unrecorded or unobserved data. The sample selected included all patients with neuraxial analgesia who underwent IVD, but a limited sample of SVD.  


Results Point of Contact:  
Name/Title: Dr. Robert J. McCarthy, PharmD
Organization: Northwestern University Feinberg School of Medicine
phone: 312-926-9015
e-mail: r-mccarthy@northwestern.edu


Publications:


Responsible Party: Cynthia A. Wong M.D., Northwestern University
ClinicalTrials.gov Identifier: NCT00443560     History of Changes
Other Study ID Numbers: 0524-028
Study First Received: March 2, 2007
Results First Received: May 9, 2011
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board