Oxytocin And Uterotonic Agent Use For Cesarean Delivery

Study Overview
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Brief Summary
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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: Reduce the side effects associated with uterotonic drug use Reduce the time to establishment and maintenance of adequate uterine tone

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of Standardized Versus Conventional Oxytocin and Uterotonic Agent Use for Cesarean Delivery

Conditions
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Uterine Atony, Hypotension

Intervention / Treatment
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* Drug: Oxytocin Infusion
* Drug: Oxytocin Bolus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) I or II health status Age between 18 and 50 yrs Singleton pregnancies in vertex position Elective (without prior labor) cesarean delivery with a planned lower uterine (pfannenstiel) incision Exclusion Criteria: Conditions that predispose to uterine atony and postpartum hemorrhage

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care Group<br>Standard Care Group (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion oxytocin. If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM (intramuscular) or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded. If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally. | Drug: Oxytocin Infusion<br>* 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.<br>* Other names: misoprostol 600 mcg buccally;|
| Active Comparator: Protocol Group<br>Protocol Group will receive 3 mL syringes marked study solution-oxytocin which contain 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). If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked study solution-9 min, containing methylergonovine maleate (methergine) 0.2mg, will be given IM. If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked study solution-12 min, containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM. If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally. | Drug: Oxytocin Bolus<br>* 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).<br>* Other names: misoprostol 600 mcg buccally;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 15 min from time of infant delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 15 min from time of infant delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine Atony, Hypotension, Cesarean Delivery, Hemorrhage, Phenylephrine, Ephedrine