Platelet Count Trends in Pre-eclamptic Parturients

NCT ID: NCT00787241

Last Updated: 2014-04-14

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

445 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-09-30

Study Completion Date

2003-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obstetric Labor Complications Preeclampsia Thrombocytopenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Mild preeclampsia

Preeclampsia without eclampsia or HELLP syndrome

No interventions assigned to this group

Severe preeclampsia

Severe preeclampsia with eclampsia and/or HELLP syndrome

No interventions assigned to this group

Mild preeclampsia superimposed on chronic hypertension

Mild preeclampsia in association with chronic hypertension

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Cynthia Wong

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cynthia A Wong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Weiner CP. Preeclampsia-eclampsia syndrome and coagulation. Clin Perinatol. 1991 Dec;18(4):713-26.

Reference Type BACKGROUND
PMID: 1837248 (View on PubMed)

Leduc L, Wheeler JM, Kirshon B, Mitchell P, Cotton DB. Coagulation profile in severe preeclampsia. Obstet Gynecol. 1992 Jan;79(1):14-8.

Reference Type BACKGROUND
PMID: 1727573 (View on PubMed)

Other Identifiers

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0524-015

Identifier Type: -

Identifier Source: org_study_id

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