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Coagulation Factor Changes Associated With Postpartum Hysterectomies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier:
NCT00456547
First received: April 3, 2007
Last updated: March 24, 2012
Last verified: March 2012
History of Changes
Results First Received: November 6, 2011  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Conditions: Obstetric Labor Complications
Hemorrhage
Complications; Cesarean Section
Intervention: Procedure: Blood Draw

  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
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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
Postpartum Hysterectomy Women that require postpartum hysterectomy for post-delivery bleeding.
Cesarean Delivery Case Controls Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy

Participant Flow:   Overall Study
    Postpartum Hysterectomy     Cesarean Delivery Case Controls  
STARTED     12     12  
COMPLETED     12     12  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Postpartum Hysterectomy Women that require postpartum hysterectomy for post-delivery bleeding.
Cesarean Delivery Case Controls Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
Total Total of all reporting groups

Baseline Measures
    Postpartum Hysterectomy     Cesarean Delivery Case Controls     Total  
Number of Participants  
[units: participants]
 		  12     12     24  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     12     12     24  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     12     12     24  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     12     12     24  



  Outcome Measures
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1.  Primary:   Fibrinogen Level at 2 Hours After Delivery   [ Time Frame: 2 hours after delivery ]
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2.  Secondary:   Platelet Counts at 2 Hours After Delivery   [ Time Frame: 2 hours after delivery ]
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3.  Secondary:   Plasminogen Levels 2 Hours After Delivery   [ Time Frame: 2 hours after delivery ]
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4.  Secondary:   Antithrombin III Levels at 2 Hours Post Delivery   [ Time Frame: 2 hours after delivery ]
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  Serious 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: Dr. Robert J McCarthy, Pharm D
Organization: Northwestern University Feinberg School of Medicine
phone: 312-926-9015
e-mail: r-mccarthy@northwestern.edu


Publications:


Responsible Party: Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier: NCT00456547     History of Changes
Other Study ID Numbers: 0524-020
Study First Received: April 3, 2007
Results First Received: November 6, 2011
Last Updated: March 24, 2012
Health Authority: United States: Institutional Review Board