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| Sponsor: | Northwestern University |
|---|---|
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00787241 |
Purpose
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 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 platelet count 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 syndrome, the admission platelet count correlated with the platelet count nadir. However, the natural progression of the platelet count has not been studied in women with mild preeclampsia, or in severely preeclamptic parturients without HELLP syndrome. We hypothesize that women with mild preeclampsia or severe preeclampsia without HELLP syndrome (as defined by the American College of Obstetricians and Gynecologist criteria), and whose admission platelet count is greater than 150,000/mL, will have a stable platelet count during the course of labor and delivery and do not require another platelet count check prior to initiation of neuraxial analgesia or removal of the epidural catheter. The purpose of this study is to determine at what value the negative predictive value of the initial platelet count is less than 100% for the development of thrombocytopenia or other coagulopathy during labor.
| Condition |
|---|
|
Labour Pre Eclampsia Thrombocytopenia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Platelet Count Trends in Pre-eclamptic Parturients: What is the Predictive Value of in Initial Platelet Count During Labor? |
Blood sample
| Estimated Enrollment: | 600 |
| Study Start Date: | September 2002 |
Parturients diagnosed with preeclampsia (mild or severe) between January 1, 2000 and December 31, 2002, will be identified through the Perinatal Database. The laboratory records (coagulation tests, liver function tests and uric acid) of these women will be abstracted from the electronic medical record. The negative predictive value of a pre-neuraxial analgesia platelet count > 150,000/mL for developing a p
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Pregnant Women
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Northestern University | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Cynthia A Wong, M.D. | Northwestern University |
More Information
| Responsible Party: | Cynthia A. Wong, M.D., Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00787241 History of Changes |
| Other Study ID Numbers: | 0524-015 |
| Study First Received: | November 6, 2008 |
| Last Updated: | February 16, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Platelets Labor Pre Eclampsia |
|
Eclampsia Pre-Eclampsia Thrombocytopenia Hypertension, Pregnancy-Induced |
Pregnancy Complications Blood Platelet Disorders Hematologic Diseases |