Platelet Count Trends in Pre-eclamptic Parturients
This study has been completed.
Sponsor:
Northwestern University
Information provided by (Responsible Party):
Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier:
NCT00787241
First received: November 6, 2008
Last updated: March 5, 2012
Last verified: March 2012
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Results First Received: August 16, 2011
| Study Type: | Observational |
|---|---|
| Study Design: | Observational Model: Cohort; Time Perspective: Retrospective |
| Conditions: |
Obstetric Labor Complications Preeclampsia Thrombocytopenia |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 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. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| 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 |
Participant Flow: Overall Study
| Mild Preeclampsia | Severe Preeclampsia | Mild Preeclampsia Superimposed on Chronic Hypertension | |
|---|---|---|---|
| STARTED | 261 | 143 | 41 |
| COMPLETED | 261 | 143 | 41 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| 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 |
| Total | Total of all reporting groups |
Baseline Measures
| Mild Preeclampsia | Severe Preeclampsia | Mild Preeclampsia Superimposed on Chronic Hypertension | Total | |
|---|---|---|---|---|
|
Number of Participants
[units: participants] |
261 | 143 | 41 | 445 |
|
Age
[units: participants] |
||||
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 261 | 143 | 41 | 445 |
| >=65 years | 0 | 0 | 0 | 0 |
|
Gender
[units: participants] |
||||
| Female | 261 | 143 | 41 | 445 |
| Male | 0 | 0 | 0 | 0 |
|
Region of Enrollment
[units: participants] |
||||
| United States | 261 | 143 | 41 | 445 |
Outcome Measures
| 1. Primary: | Positive Predictive Value of Earliest Available Platelet Count [ Time Frame: 0 to 72 hours following delivery ] |
| 2. Secondary: | Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia [ Time Frame: 0 to 72 hours following delivery ] |
| 3. Secondary: | Time Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia [ Time Frame: 1 week to time of neuraxial analgesia ] |