Coagulation Factor Changes Associated With Postpartum Hysterectomies
Information source: Northwestern University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obstetric Labor Complications; Hemorrhage; Complications; Cesarean Section
Intervention: Blood Draw (Procedure)
Phase: N/A
Status: Completed
Sponsored by: Northwestern University Official(s) and/or principal investigator(s): Cynthia A Wong, M.D., Principal Investigator, Affiliation: Northwestern University
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.
Clinical Details
Official title: Coagulation Factor Changes Associated With Postpartum Hysterectomies
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: Fibrinogen Level at 2 Hours After Delivery
Secondary outcome: Platelet Counts at 2 Hours After DeliveryPlasminogen Levels 2 Hours After Delivery Antithrombin III Levels at 2 Hours Post Delivery
Detailed description:
All women scheduled for a Cesarean-hysterectomy will be asked to enroll in the study, as
well as the women with the following diagnoses, which puts them at increased risk for
Cesarean hysterectomy: placenta previa, placenta accreta, vaginal trial of labor after a
previous Cesarean delivery.
Written, informed consent will be obtained from all subjects. A blood sample will be
obtained shortly after admission to the hospital. In women who go on to have a
hysterectomy, blood samples will be obtained at predefined time periods (at time of decision
to perform hysterectomy, with every clinically indicated blood draw for coagulation tests, 2
hours after delivery. The next patient at risk of Cesarean hysterectomy, but who does not go
on to have a hysterectomy, will serve as a cohort control. Blood samples will be drawn at 2
hours after delivery for coagulation testing. Baseline samples from all other study
subjects will be discarded and no further blood work will be obtained. The primary outcome
will be the the level of fibrinogen at 2 hours following delivery as a marker of consumptive
coagulopathy.
Every patient at risk for hemorrhage has at least one peripheral intravenous cannula
inserted upon admission to the Labor & Delivery Unit. A 2nd IV cannula is almost always
placed, usually when the decision is made to proceed with a Cesarean delivery. All study
subjects will have a 2nd IV cannula placed for drawing blood for study coagulation tests,
and any other clinically indicated blood tests. The cannula will be connected to a stopcock
with a "heparin lock" (cannula and stopcock are flushed with saline between aspirations) and
left in place for 48 hours after delivery.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Northwestern University, Chicago, Illinois 60611, United States
Additional Information
Related publications: 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. Review. Lanir N, Aharon A, Brenner B. Procoagulant and anticoagulant mechanisms in human placenta. Semin Thromb Hemost. 2003 Apr;29(2):175-84. Review. 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.
Starting date: December 2003
Last updated: March 17, 2014
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