Platelet Count Trends in Pre-eclamptic Parturients

• 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: Northwestern University
• Information provided by (Responsible Party): Cynthia Wong, Northwestern University

Study Description

Brief 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.

Condition or disease
Obstetric Labor Complications; Preeclampsia; Thrombocytopenia

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 Design

• Study Type: Observational
• Actual Enrollment: 445 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Platelet Count Trends in Pre-eclamptic Parturients: What is the Predictive Value of an Initial Platelet Count During Labor?
• Study Start Date: September 2002
• Actual Primary Completion Date: May 2003
• Actual Study Completion Date: May 2003

Groups and Cohorts

Group/Cohort
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

Outcome Measures

Primary Outcome Measures :

1. Positive Predictive Value of Earliest Available Platelet Count [ Time Frame: 0 to 72 hours following delivery ]
   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.

Secondary Outcome Measures :

1. 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.
2. Time Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia [ Time Frame: 1 week to time of neuraxial analgesia ]
   Time interval in hours from the closest obtained platelet count to the initiation of neuraxial analgesia.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Pregnant Women

Criteria

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.

Contacts and Locations

Locations

United States, Illinois

Northestern University

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

• Principal Investigator: Cynthia A Wong, M.D.; Northwestern University

More Information

Publications:

Weiner CP. Preeclampsia-eclampsia syndrome and coagulation. Clin Perinatol. 1991 Dec;18(4):713-26. Review.

Leduc L, Wheeler JM, Kirshon B, Mitchell P, Cotton DB. Coagulation profile in severe preeclampsia. Obstet Gynecol. 1992 Jan;79(1):14-8.

• Responsible Party: Cynthia Wong, Professor of Anesthesiology, Northwestern University
• ClinicalTrials.gov Identifier: NCT00787241
• Other Study ID Numbers: 0524-015
• First Posted: November 7, 2008
• Results First Posted: February 17, 2012
• Last Update Posted: April 14, 2014
• Last Verified: March 2014

Keywords provided by Cynthia Wong, Northwestern University:

Platelets; Labor; Preeclampsia

Additional relevant MeSH terms:

Pre-Eclampsia; Obstetric Labor Complications; Thrombocytopenia; Blood Platelet Disorders; Hematologic Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications