- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00787241
Platelet Count Trends in Pre-eclamptic Parturients
March 17, 2014 updated by: Cynthia Wong, Northwestern University
Platelet Count Trends in Pre-eclamptic Parturients: What is the Predictive Value of an Initial Platelet Count During Labor?
Thrombocytopenia (platelet count < 100,000/mL) occurs in approximately 15% of women with preeclampsia.
Neuraxial analgesia is contraindicated in parturients with a coagulopathy; therefore, the platelet count(PC) is routinely checked prior to the initiation of neuraxial analgesia in women with preeclampsia/eclampsia.
Catheter removal is also contraindicated in the presence of a coagulopathy.
Some women have an acceptable PC at the initiation of neuraxial analgesia, but may become significantly more thrombocytopenic during labor and delivery.
In a study of severely preeclamptic parturients, some with HELLP (H=hemolysis of red blood cells, EL=elevated liver enzymes, LP=low platelet count) syndrome, the admission PC correlated with the PC nadir.
However, the natural progression of the PC has not been studied in women with mild preeclampsia.
We hypothesize that women with mild preeclampsia or severe preeclampsia without HELLP syndrome, and whose admission PC is greater than 150,000/mL, will have a stable PC during the course of labor and delivery and do not require another PC check prior to initiation of neuraxial analgesia or removal of the epidural catheter.
The purpose of this study is to determine the positive predictive value of an initial PC greater than 150,000/mL for maintaining a PC greater than 80,000/mL during labor and delivery.
Study Overview
Status
Completed
Detailed Description
All women who delivered from 1/2000 through 12/2002, with the discharge diagnosis of mild preeclampsia, severe preeclampsia (including HELLP and eclampsia), and preeclampsia superimposed on chronic hypertension were identified through the Perinatal Database.
Platelet counts (PC) for each patient, from one month prior to the delivery admission, until hospital discharge, were analyzed.
The number of PC determinations per parturient was determined.
For each diagnosis, the positive predictive value (PPV) of an initial PC > 150,000/mL for maintaining subsequent PC > 80,000/mL, as well as the PPV of the PC prior to initiation of neuraxial analgesia was calculated.
The median time interval from the closest PC determination to initiation of neuraxial analgesia was calculated.
Study Type
Observational
Enrollment (Actual)
445
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northestern University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Pregnant Women
Description
Inclusion Criteria:
- All participants who delivered between January 1, 2000 and December 31, 2002, identified as having preeclampsia (without HELLP syndrome) in the Perinatal Database.
Exclusion Criteria:
- Participants not diagnosed with preeclampsia and/or outside the given criteria dates.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Mild preeclampsia
Preeclampsia without eclampsia or HELLP syndrome
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Severe preeclampsia
Severe preeclampsia with eclampsia and/or HELLP syndrome
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Mild preeclampsia superimposed on chronic hypertension
Mild preeclampsia in association with chronic hypertension
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive Predictive Value of Earliest Available Platelet Count
Time Frame: 0 to 72 hours following delivery
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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.
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0 to 72 hours following delivery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia
Time Frame: 0 to 72 hours following delivery
|
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.
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0 to 72 hours following delivery
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Time Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia
Time Frame: 1 week to time of neuraxial analgesia
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Time interval in hours from the closest obtained platelet count to the initiation of neuraxial analgesia.
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1 week to time of neuraxial analgesia
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cynthia A Wong, M.D., Northwestern University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Primary Completion (Actual)
May 1, 2003
Study Completion (Actual)
May 1, 2003
Study Registration Dates
First Submitted
November 6, 2008
First Submitted That Met QC Criteria
November 6, 2008
First Posted (Estimate)
November 7, 2008
Study Record Updates
Last Update Posted (Estimate)
April 14, 2014
Last Update Submitted That Met QC Criteria
March 17, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0524-015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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