Trial Outcomes & Findings for Platelet Count Trends in Pre-eclamptic Parturients (NCT NCT00787241)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

445 participants

Primary outcome timeframe

0 to 72 hours following delivery

Results posted on

2014-04-14

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Mild Preeclampsia Subjects with a discharge diagnosis of mild preeclampsia	Severe Preeclampsia Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome	Mild Preeclampsia Superimposed on Chronic Hypertension Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy
Overall Study STARTED	261	143	41
Overall Study COMPLETED	261	143	41
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Platelet Count Trends in Pre-eclamptic Parturients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mild Preeclampsia n=261 Participants Subjects with a discharge diagnosis of mild preeclampsia	Severe Preeclampsia n=143 Participants Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome	Mild Preeclampsia Superimposed on Chronic Hypertension n=41 Participants Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy	Total n=445 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	261 Participants n=5 Participants	143 Participants n=7 Participants	41 Participants n=5 Participants	445 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	261 Participants n=5 Participants	143 Participants n=7 Participants	41 Participants n=5 Participants	445 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	261 participants n=5 Participants	143 participants n=7 Participants	41 participants n=5 Participants	445 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mild Preeclampsia n=261 Participants Subjects with a discharge diagnosis of mild preeclampsia	Severe Preeclampsia n=143 Participants Subjects with a diagnosis of severe preeclampsia at discharge	Mild Preeclampsia Superimposed on Chronic Hypertension n=41 Participants Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
Positive Predictive Value of Earliest Available Platelet Count	99 percentage of positive platelet counts	90 percentage of positive platelet counts	100 percentage of positive platelet counts

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mild Preeclampsia n=261 Participants Subjects with a discharge diagnosis of mild preeclampsia	Severe Preeclampsia n=143 Participants Subjects with a diagnosis of severe preeclampsia at discharge	Mild Preeclampsia Superimposed on Chronic Hypertension n=41 Participants Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia	99 percentage of positive platelet counts	93 percentage of positive platelet counts	100 percentage of positive platelet counts

SECONDARY outcome

Timeframe: 1 week to time of neuraxial analgesia

Time interval in hours from the closest obtained platelet count to the initiation of neuraxial analgesia.

Outcome measures

Outcome measures
Measure	Mild Preeclampsia n=261 Participants Subjects with a discharge diagnosis of mild preeclampsia	Severe Preeclampsia n=143 Participants Subjects with a diagnosis of severe preeclampsia at discharge	Mild Preeclampsia Superimposed on Chronic Hypertension n=41 Participants Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension
Time Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia	4 Hours Interval 0.5 to 474.0	3 Hours Interval 0.1 to 35.3	4 Hours Interval 0.5 to 42.8

Adverse Events

Mild Preeclampsia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Severe Preeclampsia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mild Preeclampsia Superimposed on Chronic Hypertension

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert J. McCarthy

Northwestern University Feinberg School of Medicine

Phone: 312-926-9015

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place