NCT00788255|CompletedResultsDMC
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Sponsor study identifier
observational
25
1 country
1
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2009
Actual (reported)Study Completion
June 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
November 6, 2008
Actual (reported)November 10, 2008
Actual (reported)June 2009
Actual (reported)June 2009
Actual (reported)October 18, 2016
Actual (reported)r Time
thromboelastographic indices - reaction time (normal range, 5-10 min)
6 months
k Time
thromboelastographic indices - clot formation time (normal range, 1-3 min)
6 months
Alpha Angle
thromboelastographic - alpha angle = clot formation rate (normal range, 53 degress to 72 degrees)
6 months
MA
thromboelastographic indices - maximum amplitude (normal range, 50-70 mm)
6 months
MRTG
thromboelastographic indices - maximum rate of thrombus generation (normal range, 5-17 mm/min)
6 months
Tmax
thromboelastographic indices - time to initiation of clot formation plus time to achieve maximum rate of clot strength development (normal range, 6-12 min)
6 months
TTG
thromboelastographic indices - total thrombus generation (normal range, 584-796 mm)
6 months
For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows: Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
Citrated whole blood 1mL + 23μU oxytocin. After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
healthy pregnant patients awaiting elective induction of labor or cesarean delivery.
Contact the study team to confirm eligibility.
Stanford University School of Medicine
Stanford, California, 94305, United States
Venous blood
Alexander J Butwick
Stanford University
25 participants (actual enrollment reported by the registry).
First Submitted
November 6, 2008
First Posted
November 10, 2008
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Survey of Anesthesiology Residents' Perceptions of Critical Care Medicine as a Career
Citrated whole blood 1mL + 31μU oxytocin. After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
Citrated whole blood 1mL + 34μU oxytocin. After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
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Primary Completion
June 2009
Actual (reported)Study Completion
June 2009
Actual (reported)Last Updated
November 28, 2016
Results First Posted
October 18, 2016
Record last verified: 2016-10
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Source: ClinicalTrials.gov.
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