Platelet Count Trends in Pre-eclamptic Parturients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier:
NCT00787241
First received: November 6, 2008
Last updated: March 5, 2012
Last verified: March 2012
Results First Received: August 16, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Conditions: Obstetric Labor Complications
Preeclampsia
Thrombocytopenia

  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 who delivered from 1/2000 thru 12/2002 with the discharge diagnosis of mild preeclampsia, severe preeclampsia and preeclampsia superimposed on chronic hypertension were retrospectively evaluated.

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
Mild Preeclampsia Subjects with a discharge diagnosis of mild preeclampsia
Severe Preeclampsia Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
Mild Preeclampsia Superimposed on Chronic Hypertension Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy

Participant Flow:   Overall Study
    Mild Preeclampsia     Severe Preeclampsia     Mild Preeclampsia Superimposed on Chronic Hypertension  
STARTED     261     143     41  
COMPLETED     261     143     41  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Mild Preeclampsia Subjects with a discharge diagnosis of mild preeclampsia
Severe Preeclampsia Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome
Mild Preeclampsia Superimposed on Chronic Hypertension Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
Total Total of all reporting groups

Baseline Measures
    Mild Preeclampsia     Severe Preeclampsia     Mild Preeclampsia Superimposed on Chronic Hypertension     Total  
Number of Participants  
[units: participants]
  261     143     41     445  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     261     143     41     445  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     261     143     41     445  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     261     143     41     445  



  Outcome Measures
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1.  Primary:   Positive Predictive Value of Earliest Available Platelet Count   [ Time Frame: 0 to 72 hours following delivery ]

2.  Secondary:   Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia   [ Time Frame: 0 to 72 hours following delivery ]

3.  Secondary:   Time Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia   [ Time Frame: 1 week to time of neuraxial analgesia ]


  Serious Adverse Events


  Other Adverse Events


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