N/A
N=24
Coagulation Factor Changes Associated With Postpartum Hysterectomies
Obstetric Labor Complications · Hemorrhage · Complications; Cesarean Section
Bottom Line
View on ClinicalTrials.gov: NCT00456547 ↗Enrolled (actual)
24
Serious AEs
—
Results posted
Feb 2012
Primary outcome: Primary: Fibrinogen Level at 2 Hours After Delivery — 186; 418 mg/dL — p=<0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Blood Draw (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Dec 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fibrinogen Level at 2 Hours After Delivery |
186; 418 | <0.05 sig |
| SECONDARY Platelet Counts at 2 Hours After Delivery |
124; 179 | <0.05 sig |
| SECONDARY Plasminogen Levels 2 Hours After Delivery |
66; 108 | <0.05 sig |
| SECONDARY Antithrombin III Levels at 2 Hours Post Delivery |
51; 89 | <0.05 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00456547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.