Coagulation Factor Changes Associated With Postpartum Hysterectomies
Condition: Obstetric Labor Complications; Hemorrhage; Complications; Cesarean Section
MeSH terms: Obstetric Labor Complications; Hemorrhage
Study type: Observational

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.
    

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.
    

Intervention name(s): Blood Draw
Intervention type(s): Procedure
Intervention description(s): Blood was obtained for coagulation studies at 2 hours following hysterectomy or cesarean delivery.
Other intervention name(s): postpartum coagulation disorder
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant Women
      
Keywords: Cesarean hysterectomy; Postpartum hemorrhage; Coagulation