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NCT00787241 · ClinicalTrials.gov registry record
Platelet Count Trends in Pre-eclamptic Parturients
A clinical trial, sponsored by Northwestern University.
- Completed
- Registry status
- 445
- Enrollment target
NCT00787241: Completed study, sponsored by Northwestern University.
NCT00787241 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 445 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00787241 has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 445 participants
- Enrollment target
Study 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.
Primary Outcome
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 a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 445 participants |
| Start Date | 2002-09 |
| Est. Completion | 2003-05 |
What the finished NCT00787241 record still lists
NCT00787241 is an observational study that tracks outcomes without assigning an intervention. The registered 445 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00787241 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00787241 about?
NCT00787241 is a clinical study titled "Platelet Count Trends in Pre-eclamptic Parturients". 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 preec...
What is the current status of trial NCT00787241?
This trial is currently completed. The enrollment target is 445 participants. The study started on 2002-09. Estimated completion is 2003-05.
Who is sponsoring clinical trial NCT00787241?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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