The Use of Thromboelastometry (ROTEM) to Evaluate the Changes in Coagulation With Two Different Doses of Oxytocin Following Cesarean Delivery
NCT ID: NCT02063568
Last Updated: 2015-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-01-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Low dose oxytocin infusion
oxytocin will be administered as an intravenous infusion at a rate of 0.33 units/min starting after fetal delivery upon umbilical cord clamping and continuing for a total of 30 minutes
Oxytocin
High dose oxytocin infusion
oxytocin will be administered as an intravenous infusion at a rate of 1.33 units/min starting after fetal delivery upon umbilical cord clamping and continuing for a total of 30 minutes
Oxytocin
Interventions
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Oxytocin
Eligibility Criteria
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Inclusion Criteria
* Age \> or = 18 yrs
* Non-laboring women
* cesarean delivery under spinal anesthesia with pfannenstiel incision
* ASA I-III
Exclusion Criteria
* Allergy to phenylephrine
* Severe cardiac disease in pregnancy with marked functional limitations
* Women receiving NSAIDS, aspirin or other anticoagulants
* Subject enrollment in another study involving a study medication within 30 days of cesarean delivery
* Other physical or psychiatric condition which may impair the ability to cooperate with study data collection
18 Years
FEMALE
No
Sponsors
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Duke University
OTHER
Responsible Party
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Locations
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Duke University Hospital
Durham, North Carolina, United States
Countries
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References
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Solomon C, Collis RE, Collins PW. Haemostatic monitoring during postpartum haemorrhage and implications for management. Br J Anaesth. 2012 Dec;109(6):851-63. doi: 10.1093/bja/aes361. Epub 2012 Oct 16.
George RB, McKeen D, Chaplin AC, McLeod L. Up-down determination of the ED(90) of oxytocin infusions for the prevention of postpartum uterine atony in parturients undergoing Cesarean delivery. Can J Anaesth. 2010 Jun;57(6):578-82. doi: 10.1007/s12630-010-9297-1. Epub 2010 Mar 18.
Balki M, Erik-Soussi M, Kingdom J, Carvalho JC. Oxytocin pretreatment attenuates oxytocin-induced contractions in human myometrium in vitro. Anesthesiology. 2013 Sep;119(3):552-61. doi: 10.1097/ALN.0b013e318297d347.
Tita AT, Szychowski JM, Rouse DJ, Bean CM, Chapman V, Nothern A, Figueroa D, Quinn R, Andrews WW, Hauth JC. Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):293-300. doi: 10.1097/AOG.0b013e318242da74.
Butwick A, Harter S. An in vitro investigation of the coagulation effects of exogenous oxytocin using thromboelastography in healthy parturients. Anesth Analg. 2011 Aug;113(2):323-6. doi: 10.1213/ANE.0b013e3182222a82. Epub 2011 Jun 3.
Neuenschwander S, Pliska V. Effects of neurohypophyseal hormone analogues on blood clotting factor VIII and fibrinolytic activity in sheep. Eur J Pharmacol. 1997 Apr 4;323(2-3):205-13. doi: 10.1016/s0014-2999(97)00036-8.
Other Identifiers
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Pro00051122
Identifier Type: -
Identifier Source: org_study_id