In-vitro Study to Assess the Coagulation Effects of Exogenous Oxytocin Using Thromboelastography.
Oxytocin is normally administered following delivery in pregnant patients to reduce postpartum bleeding by increasing uterine tone. It is unclear whether the use of intravenous oxytocin alters coagulation in pregnant patients. The purpose of the in-vitro study is to assess the coagulation changes of oxytocin in blood samples from pregnant patients using thromboelastrography (TEG). TEG is a point-of-care device which measures the viscoelastic properties of clot formation, and can provide rapid and detailed information about coagulation changes. We aim to collect blood samples from pregnant patients to assess the in-vitro effects of synthetic oxytocin on coagulation using TEG.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||In-vitro Study to Assess the Coagulation Effects of Exogenous Oxytocin Using Thromboelastography.|
- Effect of oxytocin on coagulation as assessed by thromboelastography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
|Study Start Date:||October 2008|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
All obstetric patients presenting for elective induction of labor or elective Cesarean delivery will be informed about the study prior to and on admission to the labor and delivery unit. Admission blood sampling will take place by venepuncture for the following analysis:TEG, PT, PTT, INR, Hct, Platelet count.The results of oxytocin influence on thromboelastogram parameters will be compared to a control. The control is an aliquot of parturient blood with no added oxytocin. Thromboelastography will be used to assess coagulation changes between control samples and blood samples with added oxytocin. The results will not be used to influence clinical management of any case.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788255
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Alexander J Butwick||Stanford University|