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

November 6, 2008
March 17, 2014
September 2002
May 2003   (final data collection date for primary outcome measure)
Positive Predictive Value of Earliest Available Platelet Count [ Time Frame: 0 to 72 hours following delivery ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00787241 on ClinicalTrials.gov Archive Site
  • Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia [ Time Frame: 0 to 72 hours following delivery ] [ Designated as safety issue: No ]
    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 Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia [ Time Frame: 1 week to time of neuraxial analgesia ] [ Designated as safety issue: No ]
    Time interval in hours from the closest obtained platelet count to the initiation of neuraxial analgesia.
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Platelet Count Trends in Pre-eclamptic Parturients
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Pregnant Women

  • Obstetric Labor Complications
  • Preeclampsia
  • Thrombocytopenia
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  • Mild preeclampsia
    Preeclampsia without eclampsia or HELLP syndrome
  • Severe preeclampsia
    Severe preeclampsia with eclampsia and/or HELLP syndrome
  • Mild preeclampsia superimposed on chronic hypertension
    Mild preeclampsia in association with chronic hypertension

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
445
May 2003
May 2003   (final data collection date for primary outcome measure)

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.
Female
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00787241
0524-015
No
Cynthia Wong, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Cynthia A Wong, M.D. Northwestern University
Northwestern University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP