Clinical trial NCT02063568: The Use of Thromboelastometry (ROTEM) to Evaluate the Changes in Coagulation With Two Different Doses of Oxytocin Following Cesarean Delivery
Official title: The Use of Thromboelastometry (ROTEM) to Evaluate the Changes in Coagulation With Two Different Doses of Oxytocin Following Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coagulation Changes With Oxytocin
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: coagulation as assessed by ROTEM
timeFrame: 30 minutes after oxytocin infusion started
Secondary outcomes:
measure: cardiac output changes with oxytocin
timeFrame: from start of surgery until 30 min after oxytocin infusion started
measure: incidence of nausea and vomiting with oxytocin
timeFrame: from start of surgery until 30 minutes after oxytocin started
measure: estimated blood loss with different doses of oxytocin
timeFrame: upon completion of surgery
measure: changes in blood pressure with oxytocin
timeFrame: from start of surgery until 30 minutes after oxytocin started
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.