N/A
N=445
Platelet Count Trends in Pre-eclamptic Parturients
Obstetric Labor Complications · Preeclampsia · Thrombocytopenia
Bottom Line
View on ClinicalTrials.gov: NCT00787241 ↗Enrolled (actual)
445
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcome: Primary: Positive Predictive Value of Earliest Available Platelet Count — 99; 90; 100 percentage of positive platelet counts
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- May 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Predictive Value of Earliest Available Platelet Count |
99; 90; 100 | — |
| SECONDARY Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia |
99; 93; 100 | — |
| SECONDARY Time Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia |
4; 3; 4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- All participants who delivered between January 1, 2000 and December 31, 2002, identified as having preeclampsia (without HELLP syndrome) in the Perinatal Database.
Exclusion Criteria
- Participants not diagnosed with preeclampsia and/or outside the given criteria dates.
Data sourced from ClinicalTrials.gov (NCT00787241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.