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 17, 2014
Last verified: March 2014
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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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
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


  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
Retrospective trial and obtaining platelet counts was not done per protocol so cannot predict the greatest interval that is acceptable to demonstrate platelet counts greater than 150,000 during labor and delivery.


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


Results Point of Contact:  
Name/Title: Dr. Robert J. McCarthy
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: NCT00787241     History of Changes
Other Study ID Numbers: 0524-015
Study First Received: November 6, 2008
Results First Received: August 16, 2011
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board