Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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
Obstetric Labor Complications
Preeclampsia
Thrombocytopenia

Study Type: Observational
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 445
Study Start Date: September 2002
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787241

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:
Responsible Party: Cynthia Wong, Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT00787241     History of Changes
Other Study ID Numbers: 0524-015
Study First Received: November 6, 2008
Results First Received: August 16, 2011
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Platelets
Labor
Preeclampsia

Additional relevant MeSH terms:
Obstetric Labor Complications
Pre-Eclampsia
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on November 19, 2014