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NCT00456547 · ClinicalTrials.gov registry record

Coagulation Factor Changes Associated With Postpartum Hysterectomies

A clinical trial of Hemorrhage and Obstetric Labor Complications, sponsored by Northwestern University.

Completed
Registry status
24
Enrollment target
1
Study location

NCT00456547 is a study of Hemorrhage and Obstetric Labor Complications that has completed, run by Northwestern University. The registered enrollment target is 24 participants, below the 265-participant average among 20 other Hemorrhage trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00456547, a study of Hemorrhage and Obstetric Labor Complications, has completed, sponsored by Northwestern University.

COMPLETED
Registry status
24 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to examine components of the coagulation system in women undergoing postpartum hysterectomy and to compare laboratory parameters of coagulation in these women to women at increased risk for a postpartum hysterectomy, but who do not have postpartum hemorrhage and a postpartum hysterectomy. During normal pregnancy, the hemostatic balance tips toward hypercoagulation. Non-obstetric surgical blood loss is associated with increased coagulation activity. We have observed that women undergoing a postpartum hysterectomy become hypocoagulable secondary to a consumptive coagulopathy and/or excessive fibrinolysis. This coagulopathy may lead to the administration of multiple blood products. Worldwide, postpartum hemorrhage is a leading cause of maternal death. Plasma levels of tissue plasminogen activator, urokinase plasminogen activator and their inhibitors increase during pregnancy. During labor and delivery activation of coagulation occurs with consumption of platelets, coagulation factors and inhibitors. Obstetric complications during delivery can excessively activate the coagulation system and disseminated intravascular coagulation may ensue. Current treatment for postpartum coagulopathy is non-specific and primarily consists of replacing blood components. If specific causes or markers of abnormal coagulation can be identified in women at risk, then it might be possible to target (with specific medications) specific abnormalities early in the process and decrease hemorrhage and the need for blood transfusions.

Interventions

  • PROCEDURE Blood Draw

Study Locations (1)

Illinois

  • Northwestern University - Chicago

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2003-12
Est. Completion 2006-12

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT00456547

The ClinicalTrials.gov registry entry for NCT00456547 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 265-participant average among 20 other Hemorrhage trials with a reported enrollment target (91% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Hemorrhage appearing as the primary indexed condition, and to 1 intervention - of which Blood Draw is the first listed.

NCT00456547 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT00456547 about?

NCT00456547 is a clinical study titled "Coagulation Factor Changes Associated With Postpartum Hysterectomies". The purpose of this study is to examine components of the coagulation system in women undergoing postpartum hysterectomy and to compare laboratory parameters of coagulation in these women to women at increased risk for a postpartum hysterectomy, but who do not have postpartum hemorrhage and a postpa...

What is the current status of trial NCT00456547?

This trial is currently completed. The enrollment target is 24 participants. The study started on 2003-12. Estimated completion is 2006-12.

What conditions does trial NCT00456547 study?

This clinical trial studies the following conditions: Hemorrhage, Obstetric Labor Complications, Complications; Cesarean Section.

What interventions are being tested in trial NCT00456547?

The interventions under investigation include: Blood Draw (PROCEDURE).

Who is sponsoring clinical trial NCT00456547?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00456547 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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