The central objective of this study will be to evaluate a standardized, evidence-based regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean delivery The investigators primary hypothesis is that the proposed uterotonic drug regimen, when compared to conventional dosing regimen, during elective cesarean delivery will: 1\. Reduce the overall amount of oxytocin and other uterotonic agents used to obtain satisfactory uterine tone. Secondary outcomes to be evaluated will be: 1. Reduce the side effects associated with uterotonic drug use 2. Reduce the time to establishment and maintenance of adequate uterine tone
The current guidelines for the administration of oxytocin during cesarean delivery are diverse, empiric, and vague. A stepwise, standardized, checklist driven algorithm for the use of oxytocin and other uterotonic agents during cesarean delivery is needed to guide practitioners in a clear and concise manner. This algorithm should encompass laboring and non-laboring women, as well as prophylactic and therapeutic uses of oxytocin and other uterotonic agents. More specifically, the investigators believe that the following points should be incorporated into a protocol: 1) oxytocin should be used in initial doses of less than 5 IU; 2) oxytocin should not be administered as a rapid IV bolus; 3) an initial rapid infusion of oxytocin should be followed by a maintenance infusion; 4) higher initial and infusion doses of oxytocin offer no clinical benefit and should be avoided; and 5) if it appears that oxytocin is not producing effective uterine contractions, other uterotonic drugs acting via different pathways should be considered in a standardized way.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.
3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
Brigham and Women's Hospital
Boston, Massachusetts, United States
1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone.
Will measure total amount of oxytocin to achieve satisfactory uterine tone, as determined by the operating obstetrician.
Time frame: Up to 15 min from time of infant delivery
Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use
Number of subjects experiencing hypotension, flushing, nausea, and emesis reported after administration of uterotonic agents.
Time frame: Up to 15 min from time of infant delivery
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