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Coagulation Factor Changes Associated With Postpartum Hysterectomies
This study has been completed.
Sponsored by: Northwestern University
Information provided by: Northwestern University
ClinicalTrials.gov Identifier: NCT00456547
  Purpose

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.


Condition Intervention
Labour
Hemorrhage
Cesarean Section
Procedure: Blood Draw

MedlinePlus related topics: Bleeding Disorders Cesarean Section Hysterectomy Postpartum Care
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Coagulation Factor Changes Associated With Postpartum Hysterectomies

Further study details as provided by Northwestern University:

Estimated Enrollment: 24
Study Start Date: December 2003
Study Completion Date: November 2006
Detailed Description:

Study design: Observational with cohort control group. Methods: Size of study groups(s): The sample size calculated for this study was based upon a repeated analysis of variance measures design with 1 between factor and 1 within factor that has 2 groups with 12 subjects each for a total of 24 subjects. Each subject is measured 4 times. This design achieves 84% power to test a difference between groups if a Geisser-Greenhouse Corrected F Test is used with a 5% significance level and the actual effect standard deviation is 0.50 (an effect size of 0.63), achieves 100% power to test a difference within groups across time if a Geisser-Greenhouse Corrected F Test is used with a 5% significance level and the actual effect standard deviation is 0.50 (an effect size of 1.41), and achieves 100% power to test a group by time difference if a Geisser-Greenhouse Corrected F Test is used with a 5% significance level and the actual effect standard deviation is 0.50 (an effect size of 1.41). Patient entry, exclusion and dropout 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, which puts them at increased risk for Cesarean hysterectomy: placenta previa, placenta accreta, vaginal trial of labor after aa previous Cesarean delivery.

Protocol specific methods: 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 (anticipated N = 12), 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, 8, 24 and 48 h after delivery (approximately 9 coagulation panels per subject = approximately 70 mL per study subject for study tests). 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, 24 and 48 h after delivery for coagulation testing (4 coagulation panels per subject = 50 mL). Baseline samples from all other study subjects will be discarded and no further blood work will be obtained.

Obtaining blood for coagulation tests: 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.

Coagulation tests: Blood for coagulation tests will be withdrawn from the 16 gauge IV cannula-stopcock, after aspirating a 5 mL blank. The blank blood will be returned to the study subject immediately after the sample blood is withdrawn and the catheter-stopcock will be flushed with saline solution. The following coagulation tests will be performed at each time period: 1) complete blood count (CBC) (4 mL), prothrombin time (PT), and activated partial thromboplastin time (aPTT) (4.5 mL): NMH laboratories; 2) fibrinogen, d-dimer, antithrombin, thrombin-antithrombin complex, plasminogen, plasminogen-antiplasminogen complex (2 mL): Dr. David Green's laboratory (NU); and 3) thrombelastography (TEG) (2 mL): Dept. of Anesthesiology. The total amount of blood for each coagulation panel is 12.5 mL. If blood is withdrawn for clinically indicated coagulation tests, an extra 4 mL will be withdrawn for study tests.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant Women

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456547

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Cynthia A Wong, M.D. Northwestern University
  More Information

Publications:
Responsible Party: Northwestern University ( Cynthia A. Wong, M.D. )
Study ID Numbers: 0524-020
Study First Received: April 3, 2007
Last Updated: November 6, 2008
ClinicalTrials.gov Identifier: NCT00456547  
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Cesarean hysterectomy
Postpartum hemorrhage
Coagulation

Study placed in the following topic categories:
Postpartum Hemorrhage
Hemorrhage

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2009