Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Pregnant Women
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cynthia A Wong, M.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1837248 | Background | Weiner CP. Preeclampsia-eclampsia syndrome and coagulation. Clin Perinatol. 1991 Dec;18(4):713-26. | |
| 1727573 | Background | Leduc L, Wheeler JM, Kirshon B, Mitchell P, Cotton DB. Coagulation profile in severe preeclampsia. Obstet Gynecol. 1992 Jan;79(1):14-8. |
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mild Preeclampsia | Subjects with a discharge diagnosis of mild preeclampsia |
| FG001 | Severe Preeclampsia | Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome |
| FG002 | Mild Preeclampsia Superimposed on Chronic Hypertension | Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mild Preeclampsia | Subjects with a discharge diagnosis of mild preeclampsia |
| BG001 | Severe Preeclampsia | Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of positive platelet counts | 0 to 72 hours following delivery |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mild Preeclampsia | Subjects with a discharge diagnosis of mild preeclampsia |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert J. McCarthy | Northwestern University Feinberg School of Medicine | 312-926-9015 | r-mccarthy@northwestern.edu |
Not provided
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011225 | Pre-Eclampsia |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D046110 | Hypertension, Pregnancy-Induced |
Not provided
Not provided
Not provided
Not provided
Not provided
| 0 to 72 hours following delivery |
| Time Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia | Time interval in hours from the closest obtained platelet count to the initiation of neuraxial analgesia. | 1 week to time of neuraxial analgesia |
| BG002 | Mild Preeclampsia Superimposed on Chronic Hypertension | Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects with a diagnosis of severe preeclampsia at discharge |
| OG002 | Mild Preeclampsia Superimposed on Chronic Hypertension | Subjects with a diagnosis of mild preeclampsia at discharge with a history of chronic hypertension |
|
|
| Secondary | Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia | 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. | Posted | Number | percentage of positive platelet counts | 0 to 72 hours following delivery |
|
|
|
| Secondary | Time Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia | Time interval in hours from the closest obtained platelet count to the initiation of neuraxial analgesia. | Posted | Median | Full Range | Hours | 1 week to time of neuraxial analgesia |
|
|
|
| 0 |
| 261 |
| 0 |
| 261 |
| EG001 | Severe Preeclampsia | Subjects with a discharge diagnosis of severe preeclampsia including HELP syndrome | 0 | 143 | 0 | 143 |
| EG002 | Mild Preeclampsia Superimposed on Chronic Hypertension | Subjects with a discharge diagnosis of preeclampsia with a history of chronic hypertension prior to pregnancy | 0 | 41 | 0 | 41 |
Not provided
Not provided
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |