Sponsor study identifier
observational
24
1 country
1
Study Start
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2006
Actual (reported)Study Completion
December 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2006
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
December 2006
Actual (reported)December 2006
Actual (reported)April 3, 2007
Actual (reported)April 5, 2007
Actual (reported)February 20, 2012
Actual (reported)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
Platelet Counts at 2 Hours After Delivery
2 hours after delivery
Plasminogen Levels 2 Hours After Delivery
2 hours after delivery
Antithrombin III Levels at 2 Hours Post Delivery
2 hours after delivery
Women that require postpartum hysterectomy for post-delivery bleeding.
Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
Blood was obtained for coagulation studies at 2 hours following hysterectomy or cesarean delivery.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pregnant Women
Northwestern University
Chicago, Illinois, 60611, United States
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.
Hellgren M. Hemostasis during normal pregnancy and puerperium. Semin Thromb Hemost. 2003 Apr;29(2):125-30. doi: 10.1055/s-2003-38897.
Lanir N, Aharon A, Brenner B. Procoagulant and anticoagulant mechanisms in human placenta. Semin Thromb Hemost. 2003 Apr;29(2):175-84. doi: 10.1055/s-2003-38833.
Cynthia A Wong, M.D.
Northwestern University
24 participants (actual enrollment reported by the registry).
First Submitted
April 3, 2007
First Posted
April 5, 2007
Study Start
December 2003
Date type not reportedThis date has not been verified as actual or estimated.
An In-vitro Standardization of B Cell Elispot Assays
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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.
Primary Completion
December 2006
Actual (reported)Study Completion
December 2006
Actual (reported)Last Updated
April 14, 2014
Results First Posted
February 20, 2012
Record last verified: 2014-03
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Source: ClinicalTrials.gov.
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