The Use of Thromboelastometry (ROTEM) to Evaluate the Changes in Coagulation With Two Different Doses of Oxytocin Following Cesarean Delivery

Overview

The purpose of this study is to evaluate the differences in blood clotting seen in healthy patients given two different doses of oxytocin following cesarean delivery. The secondary objectives are to evaluate changes in blood pressure, rates of nausea and vomiting, and differences in blood loss with the two separate doses of oxytocin.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 2015

Interventions

  • Drug: Oxytocin

Arms, Groups and Cohorts

  • Active Comparator: 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
  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • coagulation as assessed by ROTEM
    • Time Frame: 30 minutes after oxytocin infusion started

Secondary Measures

  • cardiac output changes with oxytocin
    • Time Frame: from start of surgery until 30 min after oxytocin infusion started
  • incidence of nausea and vomiting with oxytocin
    • Time Frame: from start of surgery until 30 minutes after oxytocin started
  • estimated blood loss with different doses of oxytocin
    • Time Frame: upon completion of surgery
  • changes in blood pressure with oxytocin
    • Time Frame: from start of surgery until 30 minutes after oxytocin started

Participating in This Clinical Trial

Inclusion Criteria

  • English speaking
  • Age > or = 18 yrs
  • Non-laboring women
  • cesarean delivery under spinal anesthesia with pfannenstiel incision
  • ASA I-III

Exclusion Criteria

  • Height <5'0"
  • 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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Duke University
  • Provider of Information About this Clinical Study
    • Sponsor

References

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. Review.

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.

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