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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: Completed study of Hemorrhage and Obstetric Labor Complications, sponsored by Northwestern University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Fibrinogen level decrease is a marker of consumptive coagulation which is is a pathological activation of coagulation (blood clotting) mechanisms that happens in response to a variety of diseases or stimulus. We hypothesized that women with excessive bleeding following delivery who require a hysterectomy are more likely to exhibit lower levels of fibrinogen and a consumptive coagulopathy than women following cesarean delivery who do not bleed.
Conditions Studied
Interventions
- PROCEDURE Blood Draw
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2003-12 |
| Est. Completion | 2006-12 |
What the finished NCT00456547 record still lists
NCT00456547 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 265-participant average among 20 other Hemorrhage trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT00456547's enrollment target sits among peer trials
24 20th of 20 higher than 1 of 20 other Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemorrhage trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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