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Trial record 18 of 120 for:    severe preeclampsia AND delivery

Platelet Count Trends in Pre-eclamptic Parturients

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ClinicalTrials.gov Identifier: NCT00787241
Recruitment Status : Completed
First Posted : November 7, 2008
Results First Posted : February 17, 2012
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
Cynthia Wong, Northwestern University

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Conditions Obstetric Labor Complications
Preeclampsia
Thrombocytopenia
Enrollment 445
Recruitment Details 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  
Arm/Group Title Mild Preeclampsia Severe Preeclampsia Mild Preeclampsia Superimposed on Chronic Hypertension
Hide Arm/Group Description Subjects with a discharge diagnosis of mild preeclampsia Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
Period Title: Overall Study
Started 261 143 41
Completed 261 143 41
Not Completed 0 0 0
Arm/Group Title Mild Preeclampsia Severe Preeclampsia Mild Preeclampsia Superimposed on Chronic Hypertension Total
Hide Arm/Group Description Subjects with a discharge diagnosis of mild preeclampsia Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy Total of all reporting groups
Overall Number of Baseline Participants 261 143 41 445
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 261 participants 143 participants 41 participants 445 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
261
 100.0%
143
 100.0%
41
 100.0%
445
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 261 participants 143 participants 41 participants 445 participants
Female
261
 100.0%
143
 100.0%
41
 100.0%
445
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 261 participants 143 participants 41 participants 445 participants
261 143 41 445
1.Primary Outcome
Title Positive Predictive Value of Earliest Available Platelet Count
Hide Description The positive predictive value of the earliest available platelet count with the maintenance of a platelet count greater than 80,000 during labor and delivery and removal of the epidural catheter was calculated. The test was considered true if the first platelet count was >150,000 platelets and the subsequent platelet counts remained above 80,000 platelets. The number of subjects with a test equal true was divided by the total number of subjects with a platelet counts >150,000 at the earliest available platelet count multiplied by 100.
Time Frame 0 to 72 hours following delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild Preeclampsia Severe Preeclampsia Mild Preeclampsia Superimposed on Chronic Hypertension
Hide Arm/Group Description:
Subjects with a discharge diagnosis of mild preeclampsia
Subjects with a diagnosis of severe preeclampsia at discharge
Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
Overall Number of Participants Analyzed 261 143 41
Measure Type: Number
Unit of Measure: percentage of positive platelet counts
99 90 100
2.Secondary Outcome
Title Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia
Hide Description The positive predictive value of the platelet count closest to neuraxial analgesia with the maintenance of a platelet count greater than 80,000 during labor and delivery and removal of the epidural catheter was calculated. The test was considered true if the closest platelet count was >150,000 platelets and the subsequent platelet counts remained above 80,000 platelets. The number of subjects with a test equal true was divided by the total number of subjects with a platelet counts >150,000 at the closest available platelet count multiplied by 100.
Time Frame 0 to 72 hours following delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild Preeclampsia Severe Preeclampsia Mild Preeclampsia Superimposed on Chronic Hypertension
Hide Arm/Group Description:
Subjects with a discharge diagnosis of mild preeclampsia
Subjects with a diagnosis of severe preeclampsia at discharge
Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
Overall Number of Participants Analyzed 261 143 41
Measure Type: Number
Unit of Measure: percentage of positive platelet counts
99 93 100
3.Secondary Outcome
Title Time Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia
Hide Description Time interval in hours from the closest obtained platelet count to the initiation of neuraxial analgesia.
Time Frame 1 week to time of neuraxial analgesia
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mild Preeclampsia Severe Preeclampsia Mild Preeclampsia Superimposed on Chronic Hypertension
Hide Arm/Group Description:
Subjects with a discharge diagnosis of mild preeclampsia
Subjects with a diagnosis of severe preeclampsia at discharge
Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
Overall Number of Participants Analyzed 261 143 41
Median (Full Range)
Unit of Measure: Hours
4
(0.5 to 474)
3
(0.1 to 35.3)
4
(0.5 to 42.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mild Preeclampsia Severe Preeclampsia Mild Preeclampsia Superimposed on Chronic Hypertension
Hide Arm/Group Description Subjects with a discharge diagnosis of mild preeclampsia Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
All-Cause Mortality
Mild Preeclampsia Severe Preeclampsia Mild Preeclampsia Superimposed on Chronic Hypertension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mild Preeclampsia Severe Preeclampsia Mild Preeclampsia Superimposed on Chronic Hypertension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/261 (0.00%)   0/143 (0.00%)   0/41 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.1%
Mild Preeclampsia Severe Preeclampsia Mild Preeclampsia Superimposed on Chronic Hypertension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/261 (0.00%)   0/143 (0.00%)   0/41 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert J. McCarthy
Organization: Northwestern University Feinberg School of Medicine
Phone: 312-926-9015
EMail: r-mccarthy@northwestern.edu
Layout table for additonal information
Responsible Party: Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier: NCT00787241     History of Changes
Other Study ID Numbers: 0524-015
First Submitted: November 6, 2008
First Posted: November 7, 2008
Results First Submitted: August 16, 2011
Results First Posted: February 17, 2012
Last Update Posted: April 14, 2014