Platelet Count Trends in Pre-eclamptic Parturients

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00787241
Study type	Observational
Source	Northwestern University
Contact
Status	Completed
Phase	N/A
Start date	September 2002
Completion date	May 2003

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.