Hemorrhage Clinical Trial
Official title:
Coagulation Factor Changes Associated With Postpartum Hysterectomies
Verified date | March 2014 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - All women scheduled for a Cesarean-hysterectomy will be asked to enroll in the study, as well as the women with the following diagnoses, that puts them at increased risk for Cesarean hysterectomy: placenta previa, placenta accreta, vaginal trial of labor after previous Cesarean delivery. Exclusion Criteria: - Anyone who does not fit the above criteria. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
Hellgren M. Hemostasis during normal pregnancy and puerperium. Semin Thromb Hemost. 2003 Apr;29(2):125-30. Review. — View Citation
Lanir N, Aharon A, Brenner B. Procoagulant and anticoagulant mechanisms in human placenta. Semin Thromb Hemost. 2003 Apr;29(2):175-84. Review. — View Citation
Saftlas AF, Olson DR, Atrash HK, Rochat R, Rowley D. National trends in the incidence of abruptio placentae, 1979-1987. Obstet Gynecol. 1991 Dec;78(6):1081-6. — View Citation
Tuman KJ, Spiess BD, McCarthy RJ, Ivankovich AD. Effects of progressive blood loss on coagulation as measured by thrombelastography. Anesth Analg. 1987 Sep;66(9):856-63. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fibrinogen Level at 2 Hours After Delivery | 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. | 2 hours after delivery | No |
Secondary | Platelet Counts at 2 Hours After Delivery | Platelets are decreased in subjects with consumptive coagulopathies which is a pathological activation of coagulation (blood clotting) mechanisms that happens in response to a variety of diseases. We hypothesized that women who require hysterectomy for postpartum bleeding are more likely to have decreased platelet counts than matched controls that underwent cesarean delivery. | 2 hours after delivery | No |
Secondary | Plasminogen Levels 2 Hours After Delivery | Plasminogen is converted to plasmin when the coagulation system is activated. We hypothesized that plasminogen should be decrease more in women with continued bleeding following delivery requiring hysterectomy will demonstrated a greater decrease in plasminogen than following cesarean delivery. | 2 hours after delivery | No |
Secondary | Antithrombin III Levels at 2 Hours Post Delivery | Antithrombin III is a glycoprotein and is the major inhibitor of thrombin and other activated clotting factors, including factors IX, X, XI, and XII, the cofactor through which heparin exerts its effect. We hypothesized that women with continued bleed following delivery and require a hysterectomy will demonstrate a greater reduction in antithrombin III that women undergoing cesarean delivery. | 2 hours after delivery | No |
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