Platelet Count Trends in Pre-eclamptic Parturients

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00787241
• Collaborator: (none)
• Enrollment: 445
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 56

Study Details

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	Intervention/Treatment	Phase
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: Sep 1, 2002
• Actual Primary Completion Date: May 1, 2003
• Actual Study Completion Date: May 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

	Site	City	State	Country	Postal Code
1	Northestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Leduc L, Wheeler JM, Kirshon B, Mitchell P, Cotton DB. Coagulation profile in severe preeclampsia. Obstet Gynecol. 1992 Jan;79(1):14-8.
• Weiner CP. Preeclampsia-eclampsia syndrome and coagulation. Clin Perinatol. 1991 Dec;18(4):713-26. Review.

• Responsible Party: Cynthia Wong, Professor of Anesthesiology, Northwestern University
• ClinicalTrials.gov Identifier: NCT00787241
• Other Study ID Numbers: 0524-015
• First Posted: Nov 7, 2008
• Last Update Posted: Apr 14, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Cynthia Wong, Professor of Anesthesiology, Northwestern University: Platelets; Labor; Preeclampsia
• Additional relevant MeSH terms: Pre-Eclampsia; Obstetric Labor Complications; Thrombocytopenia

Study Results

Participant Flow

Recruitment Details	Women who delivered from 1/2000 thru 12/2002 with the discharge diagnosis of mild preeclampsia, severe preeclampsia and preeclampsia superimposed on chronic hypertension were retrospectively evaluated.

Arm/Group Title	Mild Preeclampsia	Severe Preeclampsia	Mild Preeclampsia Superimposed on Chronic Hypertension
Arm/Group Description	Subjects with a discharge diagnosis of mild preeclampsia	Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome	Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
Period Title: Overall Study
STARTED	261	143	41
COMPLETED	261	143	41
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Mild Preeclampsia	Severe Preeclampsia	Mild Preeclampsia Superimposed on Chronic Hypertension	Total
Arm/Group Description	Subjects with a discharge diagnosis of mild preeclampsia	Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome	Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy	Total of all reporting groups
Overall Participants	261	143	41	445
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	261 100%	143 100%	41 100%	445 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	261 100%	143 100%	41 100%	445 100%
Male	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	261 100%	143 100%	41 100%	445 100%

Outcome Measures

1. Primary Outcome

Title	Positive Predictive Value of Earliest Available Platelet Count
Description	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.
Time Frame	0 to 72 hours following delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mild Preeclampsia	Severe Preeclampsia	Mild Preeclampsia Superimposed on Chronic Hypertension
Arm/Group Description	Subjects with a discharge diagnosis of mild preeclampsia	Subjects with a diagnosis of severe preeclampsia at discharge	Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
Measure Participants	261	143	41
Number [percentage of positive platelet counts]	99	90	100

2. Secondary Outcome

Title	Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia
Description	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 Frame	0 to 72 hours following delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mild Preeclampsia	Severe Preeclampsia	Mild Preeclampsia Superimposed on Chronic Hypertension
Arm/Group Description	Subjects with a discharge diagnosis of mild preeclampsia	Subjects with a diagnosis of severe preeclampsia at discharge	Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
Measure Participants	261	143	41
Number [percentage of positive platelet counts]	99	93	100

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mild Preeclampsia	Severe Preeclampsia	Mild Preeclampsia Superimposed on Chronic Hypertension
Arm/Group Description	Subjects with a discharge diagnosis of mild preeclampsia	Subjects with a diagnosis of severe preeclampsia at discharge	Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
Measure Participants	261	143	41
Median (Full Range) [Hours]	4	3	4

Adverse Events

Arm/Group Title	Mild Preeclampsia		Severe Preeclampsia		Mild Preeclampsia Superimposed on Chronic Hypertension
Arm/Group Description	Subjects with a discharge diagnosis of mild preeclampsia		Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome		Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
All Cause Mortality
	Mild Preeclampsia		Severe Preeclampsia		Mild Preeclampsia Superimposed on Chronic Hypertension
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Mild Preeclampsia		Severe Preeclampsia		Mild Preeclampsia Superimposed on Chronic Hypertension
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/261 (0%)		0/143 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Mild Preeclampsia		Severe Preeclampsia		Mild Preeclampsia Superimposed on Chronic Hypertension
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/261 (0%)		0/143 (0%)		0/41 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.