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Platelet Count Trends in Pre-eclamptic Parturients
This study is ongoing, but not recruiting participants.

First Received on November 6, 2008.   Last Updated on February 16, 2011   History of Changes
Sponsor: Northwestern University
Information provided by: Northwestern University
ClinicalTrials.gov Identifier: NCT00787241
  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 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 platelet count 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 syndrome, the admission platelet count correlated with the platelet count nadir. However, the natural progression of the platelet count has not been studied in women with mild preeclampsia, or in severely preeclamptic parturients without HELLP syndrome. We hypothesize that women with mild preeclampsia or severe preeclampsia without HELLP syndrome (as defined by the American College of Obstetricians and Gynecologist criteria), and whose admission platelet count is greater than 150,000/mL, will have a stable platelet count during the course of labor and delivery and do not require another platelet count check prior to initiation of neuraxial analgesia or removal of the epidural catheter. The purpose of this study is to determine at what value the negative predictive value of the initial platelet count is less than 100% for the development of thrombocytopenia or other coagulopathy during labor.


Condition
Labour
Pre Eclampsia
Thrombocytopenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet Count Trends in Pre-eclamptic Parturients: What is the Predictive Value of in Initial Platelet Count During Labor?

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Biospecimen Retention:   Samples Without DNA

Blood sample


Estimated Enrollment: 600
Study Start Date: September 2002
Detailed Description:

Parturients diagnosed with preeclampsia (mild or severe) between January 1, 2000 and December 31, 2002, will be identified through the Perinatal Database. The laboratory records (coagulation tests, liver function tests and uric acid) of these women will be abstracted from the electronic medical record. The negative predictive value of a pre-neuraxial analgesia platelet count > 150,000/mL for developing a p

  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:

  • All participants not fitting above criteria.
  Contacts and Locations
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 A. Wong, M.D., Northwestern University
ClinicalTrials.gov Identifier: NCT00787241     History of Changes
Other Study ID Numbers: 0524-015
Study First Received: November 6, 2008
Last Updated: February 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Platelets
Labor
Pre Eclampsia

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

ClinicalTrials.gov processed this record on February 09, 2012