Sponsor study identifier
observational
445
1 country
1
Study Start
September 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2003
Actual (reported)Study Completion
May 2003
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2003
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2002
Date type not reportedThis date has not been verified as actual or estimated.
May 2003
Actual (reported)May 2003
Actual (reported)November 6, 2008
Actual (reported)November 7, 2008
Actual (reported)February 17, 2012
Actual (reported)Positive Predictive Value of Earliest Available Platelet Count
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.
0 to 72 hours following delivery
Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia
0 to 72 hours following delivery
Time Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia
1 week to time of neuraxial analgesia
Preeclampsia without eclampsia or HELLP syndrome
Severe preeclampsia with eclampsia and/or HELLP syndrome
Mild preeclampsia in association with chronic hypertension
Pregnant Women
Northestern University
Chicago, Illinois, 60611, United States
Weiner CP. Preeclampsia-eclampsia syndrome and coagulation. Clin Perinatol. 1991 Dec;18(4):713-26.
Leduc L, Wheeler JM, Kirshon B, Mitchell P, Cotton DB. Coagulation profile in severe preeclampsia. Obstet Gynecol. 1992 Jan;79(1):14-8.
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.
Cynthia A Wong, M.D.
Northwestern University
445 participants (actual enrollment reported by the registry).
First Submitted
November 6, 2008
First Posted
November 7, 2008
Study Start
September 2002
Date type not reportedThis date has not been verified as actual or estimated.
Study to Determine if Serum BNP Levels Are Elevated in Pregnant Women With Pre-Eclampsia
Contact the study team to confirm eligibility.
Primary Completion
May 2003
Actual (reported)Study Completion
May 2003
Actual (reported)Last Updated
April 14, 2014
Results First Posted
February 17, 2012
Record last verified: 2014-03
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Source: ClinicalTrials.gov.
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