Platelet Count Trends in Pre-eclamptic Parturients

NCT00787241 | Completed Results

• 1 other identifier: 0524-015
• Study Type: observational
• Target: 445
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Labor Complications; Preeclampsia; Thrombocytopenia

Keywords

Platelets; Labor; Preeclampsia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant Women

You may qualify if:

• All participants who delivered between January 1, 2000 and December 31, 2002, identified as having preeclampsia (without HELLP syndrome) in the Perinatal Database.

You may not qualify if:

• Participants not diagnosed with preeclampsia and/or outside the given criteria dates.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

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

  PMID: 1837248 BACKGROUND

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

  PMID: 1727573 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor Complications; Pre-Eclampsia; Thrombocytopenia

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Robert J. McCarthy
• Organization: Northwestern University Feinberg School of Medicine

r-mccarthy@northwestern.edu

312-926-9015

Study Officials

• Cynthia A Wong, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: September 1, 2002
• Primary Completion: May 1, 2003
• Study Completion: May 1, 2003
• Last Updated: April 14, 2014
• Results First Posted: February 17, 2012

Record last verified: 2014-03

Locations

US (1)